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A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

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ClinicalTrials.gov Identifier: NCT00663208
Recruitment Status : Completed
First Posted : April 22, 2008
Results First Posted : October 14, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Daclatasvir
Drug: Placebo
Enrollment 167
Recruitment Details 167 enrolled; 30 entered treatment Period. Reasons for not entering: 1 lost to follow-up, 4 withdrew consent, 5 administrative reasons, 6 other, 121 did not meet study criteria.
Pre-assignment Details A total of 30 participants received study treatment.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description Participants received once daily (QD) dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received twice daily (BID) dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Period Title: Treatment Period
Started 4 4 4 4 4 4 6
Completed 4 3 4 4 4 4 6
Not Completed 0 1 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             0             1             0             0             0             0             0
Period Title: Follow-up Period
Started 4 3 4 4 4 4 6
Completed 1 3 1 2 4 4 5
Not Completed 3 0 3 2 0 0 1
Reason Not Completed
Lost to Follow-up             2             0             3             2             0             0             0
Other reason             1             0             0             0             0             0             1
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo Total
Hide Arm/Group Description Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel. Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 4 4 6 30
Hide Baseline Analysis Population Description
The analysis was performed on all treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 6 participants 30 participants
39.5  (9.95) 46.5  (13.00) 47.5  (3.70) 39.5  (7.55) 44.8  (6.40) 44.3  (6.90) 48.0  (4.20) 44.5  (7.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 6 participants 30 participants
Female
1
  25.0%
1
  25.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
  25.0%
1
  16.7%
5
  16.7%
Male
3
  75.0%
3
  75.0%
4
 100.0%
3
  75.0%
4
 100.0%
3
  75.0%
5
  83.3%
25
  83.3%
1.Primary Outcome
Title Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants
Hide Description The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.
Time Frame Baseline, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least 1 dose of study medication.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 4 4 4 6
Mean (90% Confidence Interval)
Unit of Measure: log10 IU/mL
-2.13
(-3.10 to -1.16)
-3.31
(-4.28 to -2.34)
-2.91
(-3.88 to -1.94)
-2.58
(-3.55 to -1.61)
-3.03
(-4.00 to -2.07)
-3.56
(-4.52 to -2.59)
0.00
(-0.86 to 0.87)
2.Secondary Outcome
Title Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance
Hide Description The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 international units/ millilitre (IU/mL). Baseline was Day -1
Time Frame Baseline, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least 1 dose of study medication.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 3 3 3 6
Mean (90% Confidence Interval)
Unit of Measure: log10 IU/mL
-2.13
(-3.10 to -1.16)
-3.31
(-4.28 to -2.34)
-2.91
(-3.88 to -1.94)
-2.58
(-3.55 to -1.61)
-3.03
(-4.00 to -2.07)
-3.56
(-4.52 to -2.59)
0.00
(-0.86 to 0.87)
3.Secondary Outcome
Title Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance
Hide Description The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.
Time Frame Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182..
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 3 3 3 6
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Hour 2 0.02  (0.137) -0.00  (0.083) -0.21  (0.244) -0.43  (0.324) -0.35  (0.284) 0.04  (0.107) -0.00  (0.216)
Change at Hour 4 -0.78  (0.273) -0.91  (0.206) -1.22  (0.202) -1.24  (0.711) -1.24  (0.397) -1.01  (0.345) 0.07  (0.248)
Change at Hour 6 -1.47  (0.466) -1.73  (0.272) -2.05  (0.237) -1.96  (0.717) -1.99  (0.552) -1.36  (0.473) 0.00  (0.209)
Change at Hour 8 -1.92  (0.516) -2.12  (0.216) -2.62  (0.195) -2.47  (0.733) -2.59  (0.509) -1.74  (0.917) -0.01  (0.251)
Change at Hour 12 -2.18  (0.439) -2.44  (0.092) -2.91  (0.083) -3.08  (0.562) -2.92  (0.511) -2.00  (1.158) -0.01  (0.284)
Change at Hour 16 -2.09  (0.420) -2.76  (0.183) -2.95  (0.250) -3.38  (0.521) -3.04  (0.535) -2.03  (1.009) -0.00  (0.246)
Change at Hour 20 -1.92  (0.447) -2.80  (0.095) -3.02  (0.086) -3.50  (0.312) -3.38  (0.477) -2.29  (1.240) 0.01  (0.155)
Change at Hour 24 -1.82  (0.480) -2.97  (0.216) -3.24  (0.103) -3.60  (0.204) -3.53  (0.624) -2.58  (1.292) 0.02  (0.246)
4.Secondary Outcome
Title Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance
Hide Description The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.
Time Frame Baseline to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 3 3 3 6
Mean (90% Confidence Interval)
Unit of Measure: log10 IU/mL
-2.16
(-2.68 to -1.64)
-3.29
(-3.81 to -2.77)
-3.04
(-3.56 to -2.52)
-3.85
(-4.45 to -3.25)
-3.82
(-4.42 to -3.22)
-3.14
(-3.74 to -2.54)
-0.07
(-0.49 to 0.36)
5.Secondary Outcome
Title Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance
Hide Description The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 3 3 3 6
Mean (90% Confidence Interval)
Unit of Measure: log10 IU/mL
-1.89
(-3.38 to -0.39)
-2.32
(-3.81 to -0.82)
-1.68
(-3.17 to -0.18)
-1.34
(-3.07 to 0.39)
-3.55
(-5.27 to -1.82)
-1.35
(-3.07 to 0.38)
-0.59
(-1.81 to 0.63)
6.Secondary Outcome
Title Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance
Hide Description Participants without baseline drug resistance were assessed for time to reach maximum decrease in log10 HCV RNA level.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 3 3 3 6
Mean (Standard Deviation)
Unit of Measure: Days
4.50  (4.726) 5.25  (2.363) 3.50  (2.380) 3.33  (1.528) 10.33  (6.028) 7.67  (6.429) 10.17  (6.524)
7.Secondary Outcome
Title Maximum Decline From Baseline in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance
Hide Description The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 3 3 3 6
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-2.81  (0.700) -3.63  (0.776) -3.31  (0.050) -4.03  (0.626) -4.88  (1.335) -3.62  (0.170) -1.32  (1.629)
8.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Daclatasvir on Days 1 and 14
Hide Description The peak concentrations in plasma (Cmax) and minimum observed plasma concentration (Cmin) were defined as the peak maximum and minimum plasma level of daclatasvir, derived from plasma concentration-time data analyzed by non-compartmental methods. Cmax and Cmin of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.
Time Frame 0 hour (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13 and 24, 48 and 72 hours (post morning dose) at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication and with available Pharmacokinetic (PK) data were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Overall Number of Participants Analyzed 4 4 4 4 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliters(ng/mL)
Cmax at Day 1
15.731
(48%)
159.665
(41%)
483.365
(25%)
1409.202
(13%)
563.569
(26%)
1960.732
(21%)
Cmax at Day 14
10.430
(76%)
154.196
(49%)
555.878
(38%)
1726.383
(21%)
831.792
(37%)
1853.925
(26%)
Cmin at Day 1
1.212
(105%)
15.141
(49%)
41.114
(34%)
129.822
(25%)
171.330
(53%)
174.642
(21%)
Cmin at Day 14
1.234
(95%)
23.674
(53%)
61.635
(42%)
254.602
(42%)
206.941
(74%)
287.852
(37%)
9.Secondary Outcome
Title Area Under the Concentration-time Curve (AUC) in 1 Dosing Interval of Daclatasvir at Days 1 and 14
Hide Description The area under the concentration-time curve in 1 Dosing Interval AUC(TAU) was used to measure the drug exposure over 1 dosing interval., derived from plasma concentration-time data analyzed by non-compartmental methods. AUC(TAU) of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.
Time Frame 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication and with available PK data were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Overall Number of Participants Analyzed 4 4 4 4 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
Day 1
111.8
(54%)
1113.6
(38%)
3528.6
(19%)
10691.5
(20%)
3307.2
(36%)
15136.1
(19%)
Day 14
92.0
(80%)
1332.1
(46%)
4391.3
(27%)
15120.9
(35%)
5431.6
(35%)
17592.8
(15%)
10.Secondary Outcome
Title Plasma Half-life (T-half) of Daclatasvir at Day 14
Hide Description The absolute values of lamda (λ) were used to evaluate apparent terminal half-life (T-half) was defined as T-half= ln 2/λ. T-half was derived from plasma concentration-time data analyzed by non-compartmental methods. T-half of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.
Time Frame 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
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Hide Analysis Population Description
All participants who received at least 1 dose of study medication and with available PK data were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Overall Number of Participants Analyzed 4 4 4 4 4 4
Mean (Standard Deviation)
Unit of Measure: h
11.68  (2.214) 14.31  (3.848) 12.99  (2.039) 12.81  (1.233) 13.04  (3.654) 15.19  (3.411)
11.Secondary Outcome
Title Apparent Total Body Clearance (CLT/F) of Daclatasvir on Day 14
Hide Description The apparent total body clearance at steady state (CLT/F) was defined as the apparent body clearance of canakinumab from the serum when the systemic availability was unknown. CLT/F was derived from plasma concentration-time data analyzed by non-compartmental methods. CLT/F of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.
Time Frame 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication and with available PK data were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Overall Number of Participants Analyzed 4 4 4 4 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
181.118
(52%)
125.119
(52%)
113.861
(25%)
66.133
(29%)
92.054
(35%)
94.736
(15%)
12.Secondary Outcome
Title Average Observed Plasma Concentration (Css-av) at Steady State of Daclatasvir at Days 1 and 14
Hide Description The average observed plasma concentration at steady state (Css-av) was calculated as ratio of AUC(TAU) by TAU, where TAU = 24 h for QD dosing and 12 h for BID dosing. Css-av was derived from plasma concentration-time data analyzed by non-compartmental methods. Css-av of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.
Time Frame 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11,13, and 24, 48 and 72 hours (post morning dose) at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication and with available PK data were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Overall Number of Participants Analyzed 4 4 4 4 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1
4.659
(54%)
46.401
(38%)
147.024
(19%)
445.478
(20%)
275.596
(36%)
630.673
(19%)
Day 14
3.834
(80%)
55.503
(46%)
182.972
(27%)
630.039
(35%)
452.634
(35%)
733.035
(15%)
13.Secondary Outcome
Title Accumulation Index (AI) AUC(TAU), AI Cmax, and Degree of Fluctuation (DF) of Daclatasvir on Day 14
Hide Description Accumulation index area under the concentration-time curve of daclatasvir to the end of the dosing period [AI AUC(TAU)] was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose.Accumulation index maximum observed concentration of daclatasvir in plasma (AI Cmax) was defined as the ratio of Cmax at steady-state to Cmax after the first dose. Degree of Fluctuation (DF) was defined as the ratio of difference between Cmax and Cmin at steady state by Css-av. The parameters were analyzed using non-compartmental methods, assayed by validated liquid chromatography tandem mass spectrometry (LC-MS/MS).
Time Frame 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication and with available PK data were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Overall Number of Participants Analyzed 4 4 4 4 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
AI AUC(TAU)
0.823
(29%)
1.196
(16%)
1.245
(20%)
1.414
(17%)
1.642
(16%)
1.162
(25%)
AI Cmax
0.663
(57%)
0.966
(26%)
1.150
(28%)
1.225
(10%)
1.476
(32%)
0.946
(42%)
Degree of Fluctuation
2.389
(13%)
2.335
(18%)
2.659
(25%)
2.321
(24%)
1.251
(18%)
2.133
(12%)
14.Secondary Outcome
Title Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir on Days 1 and 14
Hide Description Tmax was defined as the time to reach maximum observed plasma concentration of daclatasvir in plasma. Tmax was derived from plasma concentration-time data analyzed by non-compartmental methods. Tmax of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.
Time Frame 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication and with available PK data were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Overall Number of Participants Analyzed 4 4 4 4 4 4
Median (Full Range)
Unit of Measure: h
Day 1
2.000
(1.00 to 3.00)
1.000
(1.00 to 2.00)
1.000
(0.50 to 1.00)
1.500
(1.50 to 3.00)
2.500
(1.50 to 3.00)
1.500
(1.00 to 1.50)
Day 14
1.250
(1.00 to 2.00)
1.250
(1.00 to 1.50)
1.000
(1.00 to 1.50)
1.000
(1.00 to 2.00)
1.750
(1.00 to 2.00)
1.750
(1.00 to 2.00)
15.Secondary Outcome
Title Correlation Coefficients Between Measures of Decline in log10 Hepatitis C Virus (HCV) RNA and Daclatasvir PK Parameters Cmax, AUC(TAU), and Cmin on Day 14 in Participants Without Baseline Drug Resistance
Hide Description Correlation between decline of log10 hepatitis C virus (HCV) RNA and exposure to study drug was measured by Pearson Correlation Coefficients. The change from baseline at Day 4 in log10 HCV RNA and the maximum decline in log10 HCV RNA were evaluated against the PK parameters Cmax, Cmin and AUC(TAU).
Time Frame Day 4, Day 14
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Hide Analysis Population Description
All participants who received at least 1 dose of daclatasvir and who had no baseline genotype resistance were analyzed. Placebo participants were excluded from this analysis.
Arm/Group Title All Daclatasvir Treated Participants
Hide Arm/Group Description:
All participants who received daclatasvir during 14 day treatment period.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Correlation Coefficient
Cmax and Delta log10 HCV RNA at Day 4 -0.61
AUC(Tau) and Delta log10 HCV RNA at Day 4 -0.61
Cmin and Delta log10 HCV RNA at Day 4 -0.63
Cmax and Maximum Decline in log10 HCV RNA -0.51
AUC(Tau) and Maximum Decline in log10 HCV RNA -0.50
Cmin and Maximum Decline in log10 HCV RNA -0.59
16.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), and Who Died
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Time Frame Day 1 to Day 182 or Day of Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 4 4 4 6
Measure Type: Number
Unit of Measure: participants
SAEs 0 0 0 0 0 0 0
Discontinuation Due to AEs 0 0 0 0 0 0 0
Death 0 0 0 0 0 0 0
17.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities in Hematology
Hide Description Hematology marked laboratory abnormalities were defined as Hemoglobin (g/dL) Low as < 0.85*Pre-therapy (PreRx), Hematocrit (%) Low as < 0.85*PreRx, Platelet Count *10^9 c/L Low as < 0.85*Lower Limits of Normal (LLN) if PreRx = Missing/< 0.85*LLN if PreRx >= LLN/< 0.85*PreRx if PreRx < LLN, Eosinophils (absolute) *10^3 c/µL High as > 0.75*count, Leukocytes White Blood Cell (WBC) *10^3 c/µL High as > 1.2*ULN if LLN <= PreRx <= Upper Limits of Normal (ULN) > 1.2*ULN if PreRx = Missing/> 1.5*PreRx if PreRx > ULN/> ULN if PreRx < LLN.
Time Frame Screening, Day 3, Day 7, Day 11, Day 14, and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated with study drug were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 4 4 4 6
Measure Type: Number
Unit of Measure: participants
Low Hematocrit 0 0 0 1 0 0 0
Low Hemoglobin 1 0 0 1 0 0 1
Low Platelet 0 0 0 0 0 1 0
High Eosinophils 0 0 0 0 0 1 0
High Leukocytes 0 0 0 0 0 1 0
18.Secondary Outcome
Title Number of Participants With Marked Abnormalities in Liver and Kidney Function Laboratory Tests and Electrolytes
Hide Description Liver and kidney function marked laboratory abnormalities were defined as Alanine Aminotransferase (ALT) units per liter (U/L) High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Aspartate Aminotransferase (AST) U/L High as > 1.25* PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Alkaline Phosphatase(ALP)U/L High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, G-Glutamyl Transferase (GGT) in U/L High as >1.15*ULN if PreRx<=ULN/>1.15* if PreRx missing/>1.2* PreRx if PreRx>ULN, Phosphorus Inorganic (mg/dL) Low as < 0.85*LLN if LLN <= PreRx <= ULN/< 0.85*LLN if PreRx = Missing/< 0.85*PreRx if PreRx < LLN/< LLN if PreRx > ULN, and Potassium serum milliequivalents per liter (mEq/L) High as > 1.1*PreRx if PreRx > ULN/> 1.1*ULN if LLN <= PreRx <= ULN/> 1.1*ULN if PreRx = Missing/> ULN if PreRx < LLN.
Time Frame Screening, Day 3, Day 7, Day 11, Day 14, and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were treated with study drug were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 4 4 4 6
Measure Type: Number
Unit of Measure: participants
ALT High 0 1 0 1 2 2 0
AST High 0 1 0 0 2 2 1
ALP High 0 0 0 0 0 1 0
GGT 0 0 2 0 2 1 2
Phosporus Low 1 0 0 0 0 0 0
Potassium High 0 0 1 0 0 0 1
19.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities in Lipase and Glucose
Hide Description Marked abnormalities were defined as Lipase (U/L) High as >1.5*ULN, Glucose fasting serum (mg/dL) High as > 1.3*ULN if LLN <= PreRx <= ULN/> 1.3*ULN if PreRx = Missing/>2*PreRx; if PreRx > ULN/> ULN if PreRx < LLN.
Time Frame Screening, Day 3, Day 7, Day 11, Day 14, and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated with study drug were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 4 4 4 6
Measure Type: Number
Unit of Measure: participants
Lipase High 0 1 0 0 1 0 0
Glucose Fasting High 0 0 0 0 0 1 1
20.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities in Urinalysis
Hide Description Marked laboratory abnormalities in urinalysis were defined as, Blood Urine High as >= 2*PreRx if PreRx >= 1/>= 2 if PreRx < 1/>= 2 if PreRx = Missing. Glucose Urine High as >= 1 if PreRx < 1/>= 1 if PreRx = Missing/>= 2*PreRx if PreRx >= 1.
Time Frame Screening, Day 3, Day 7, Day 11, Day 14, and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated with study drug were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 4 4 4 6
Measure Type: Number
Unit of Measure: participants
Urine Blood High 1 1 0 1 0 0 1
Urine Glucose High 1 0 0 0 0 0 2
21.Secondary Outcome
Title Number of Participants With Clinically Relevant Change From Baseline in Vital Signs
Hide Description Vital signs included: body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. Blood pressure and heart rate were measured after the participant had been supine, semi-supine, or seated quietly for at least 5 minutes. Baseline was defined as the last observation prior to dosing on Day 1.
Time Frame Screening, Day -1 and prior to morning dose on Day 1, 2, 14, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated with study drug were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 4 4 4 6
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0
22.Secondary Outcome
Title Number of Participants Meeting Pre-Specified Criteria in Electrocardiogram Parameters
Hide Description Pre-specified criteria were defined as, Heart rate (HR) minimum as <=50 bpm/change from baseline <-20 bpm/maximum HR >100 bpm, QT interval corrected using Fridericia's formula (QTcF) maximum as QTcF<=450 msec/450 msec <maximum QTcF and <=480 msec/480 msec <maximum QTcF <= 500 msec/maximum QTcF>500 msec, QRS interval as <=120 msec/>120 msec, and PR interval maximum as <= 200 msec/>200 msec.
Time Frame Screening, Day 2, 3, 5, 7, 9, 11, 13, 15, 21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated with study drug were summarized.
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Daclatasvir (30 mg) BID Daclatasvir (100 mg) QD Placebo
Hide Arm/Group Description:
Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
Overall Number of Participants Analyzed 4 4 4 4 4 4 6
Measure Type: Number
Unit of Measure: participants
Heart Rate <=50 bpm 0 0 0 0 0 0 0
Heart Rate > 100 bpm 0 0 0 0 0 0 0
HR Change from baseline <-20bpm 0 0 0 0 4 0 0
Maximum QTcF <= 450 msec 4 4 4 4 4 4 6
Maximum QTcF >450 msec 0 0 0 0 0 0 0
Maximum Delta QTcF<=30 4 4 4 4 4 4 6
Maximum Delta QTcF >30 msec 0 0 0 0 0 0 0
Maximum QRS <=120 msec 4 4 4 4 4 4 6
Maximum QRS > 120 msec 0 0 0 0 0 0 0
Maximum PR <=200 msec 4 4 4 4 4 4 6
Maximum PR > 200 msec 0 0 0 0 0 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (100 mg) QD Daclatasvir (30 mg) BID Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Placebo
Hide Arm/Group Description Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received Daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182. Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
All-Cause Mortality
Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (100 mg) QD Daclatasvir (30 mg) BID Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (100 mg) QD Daclatasvir (30 mg) BID Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daclatasvir (1 mg) QD Daclatasvir (10 mg) QD Daclatasvir (100 mg) QD Daclatasvir (30 mg) BID Daclatasvir (30 mg) QD Daclatasvir (60 mg) QD Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   4/4 (100.00%)   2/4 (50.00%)   2/4 (50.00%)   3/4 (75.00%)   4/4 (100.00%)   4/6 (66.67%) 
Eye disorders               
Vision blurred  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Visual acuity reduced  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders               
Vomiting  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Diarrhoea  1  0/4 (0.00%)  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Flatulence  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Abdominal discomfort  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Abdominal pain  1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Dyspepsia  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Nausea  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Dry mouth  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Gingival pain  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Abdominal pain upper  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Faeces discoloured  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
General disorders               
Energy increased  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Fatigue  1  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Infections and infestations               
Sinusitis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Urethritis  1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications               
Eye injury  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Tongue injury  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Investigations               
Electrocardiogram T wave abnormal  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders               
Pain in extremity  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Cervical spinal stenosis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Back pain  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Arthralgia  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Muscle spasms  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Nervous system disorders               
Headache  1  0/4 (0.00%)  1/4 (25.00%)  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%)  2/4 (50.00%)  2/6 (33.33%) 
Syncope  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Dizziness  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Sinus headache  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Somnolence  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Psychiatric disorders               
Insomnia  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Restlessness  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Nightmare  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Sleep disorder  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Rhinorrhoea  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders               
Photosensitivity reaction  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Dry skin  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Vascular disorders               
Hot flush  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00663208    
Other Study ID Numbers: AI444-004
First Submitted: April 18, 2008
First Posted: April 22, 2008
Results First Submitted: August 14, 2015
Results First Posted: October 14, 2015
Last Update Posted: October 14, 2015