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A Study of LY3009104 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01536951
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy Participants
Interventions Drug: LY3009104
Drug: Placebo
Drug: moxifloxacin
Enrollment 62
Recruitment Details  
Pre-assignment Details The study had 2 parts. Part A: single-dose, dose-escalating study of LY3009104 [up to 40 milligrams (mg)] or placebo administered in each period. Part B: assessed the electrophysiological effects of a single supratherapeutic LY3009104 dose compared to a positive control (moxifloxacin) and placebo. Participants enrolled in either Part A or Part B.
Arm/Group Title Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104 Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104 Part B: 40 mg LY3009104, Placebo, Moxifloxacin Part B: Placebo, Moxifloxacin, 40 mg LY3009104 Part B: Moxifloxacin, 40 mg LY3009104, Placebo Part B: Moxifloxacin, Placebo, 40 mg LY3009104 Part B: 40 mg LY3009104, Moxifloxacin, Placebo Part B: Placebo, 40 mg LY3009104, Moxifloxacin
Hide Arm/Group Description

First Intervention: Placebo tablets [matching 20-mg LY3009104] administered orally once.

Second Intervention: 30-mg LY3009104 dose administered orally once.

Third Intervention: 40-mg LY3009104 dose administered orally once.

There was a washout of at least 3 days between each intervention.

First Intervention: 20-mg LY3009104 dose administered orally once.

Second Intervention: 30-mg LY3009104 dose administered orally once.

Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.

There was a washout of at least 3 days between each intervention.

First Intervention: 20-mg LY3009104 dose administered orally once.

Second Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once.

Third Intervention: 40-mg LY3009104 dose administered orally once.

There was a washout of at least 3 days between each intervention.

First Intervention: 40-mg LY3009104 dose administered orally once.

Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.

Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.

There was a washout of at least 3 days between each intervention.

First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.

Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.

Third Intervention: 40-mg LY3009104 dose administered orally once.

There was a washout of at least 3 days between each intervention.

First Intervention: A single 400-mg moxifloxacin tablet administered orally once.

Second Intervention: 40-mg LY3009104 dose administered orally once.

Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.

There was a washout of at least 3 days between each intervention.

First Intervention: A single 400-mg moxifloxacin tablet administered orally once.

Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.

Third Intervention: 40-mg LY3009104 dose administered orally once.

There was a washout of at least 3 days between each intervention.

First Intervention: 40-mg LY3009104 dose administered orally once.

Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.

Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.

There was a washout of at least 3 days between each intervention.

First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.

Second Intervention: 40-mg LY3009104 dose administered orally once.

Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.

There was a washout of at least 3 days between each intervention.

Period Title: First Intervention and Washout Period 1
Started 3 3 3 8 9 9 9 9 9
Received at Least 1 Dose of Study Drug 3 [1] 3 3 8 9 9 9 9 9
Completed 3 3 2 8 9 9 9 9 9
Not Completed 0 0 1 0 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             0             0             0             0
[1]
Across all reporting groups, study drug is LY3009104, moxifloxacin, or placebo.
Period Title: Second Intervention and Washout Period 2
Started 3 3 2 8 9 9 9 9 9
Completed 3 3 2 8 9 9 9 8 9
Not Completed 0 0 0 0 0 0 0 1 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1             0
Period Title: Third Intervention
Started 3 3 2 8 9 9 9 8 9
Completed 3 3 2 8 9 9 9 8 9
Not Completed 0 0 0 0 0 0 0 0 0
Arm/Group Title Part A (LY3009104 or Placebo) Part B (LY3009104, Moxifloxacin, or Placebo) Total
Hide Arm/Group Description Participants were randomized to 1 of 3 treatment sequences during Part A of the study and received a single dose (LY3009104 or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as either 20-milligrams (mg), 30-mg or 40-mg dose. Participants were randomized to 1 of 6 treatment sequences during Part B of the study and received a single dose (LY3009104, moxifloxacin, or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as a 40-mg dose. Moxifloxacin was administered as a 400-mg tablet. Total of all reporting groups
Overall Number of Baseline Participants 9 53 62
Hide Baseline Analysis Population Description
Participants who received at least 1 dose of LY3009104, moxifloxacin, or placebo and had at least 1 postdose safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 53 participants 62 participants
45.9  (15.4) 39.9  (11.3) 40.8  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 53 participants 62 participants
Female
4
  44.4%
10
  18.9%
14
  22.6%
Male
5
  55.6%
43
  81.1%
48
  77.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 53 participants 62 participants
Hispanic or Latino
3
  33.3%
21
  39.6%
24
  38.7%
Not Hispanic or Latino
6
  66.7%
32
  60.4%
38
  61.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 53 participants 62 participants
Black or African American 1 12 13
White 8 39 47
More than 1 race 0 2 2
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants 53 participants 62 participants
9 53 62
1.Primary Outcome
Title Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval
Hide Description The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period [-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.
Time Frame Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in Part B of the study who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo).
Arm/Group Title Part B: Placebo Part B: 40 mg LY3009104 Part B: Moxifloxacin
Hide Arm/Group Description:
Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
Overall Number of Participants Analyzed 52 53 53
Mean (Standard Deviation)
Unit of Measure: milliseconds (msec)
1 h postdose (n=52, 53, 53) -2.5  (4.9) -2.4  (5.0) 9.7  (5.8)
1.5 h postdose (n=52, 53, 53) -1.7  (3.9) 0.1  (5.5) 9.3  (5.8)
2 h postdose (n=52, 53, 53) -1.4  (6.5) -0.1  (5.3) 9.5  (6.9)
3 h postdose (n=52, 53, 53) -2.8  (5.7) -2.5  (4.9) 9.2  (6.2)
4 h postdose (n=52, 53, 53) -1.3  (5.2) -0.8  (6.2) 9.9  (5.5)
6 h postdose (n=51, 53, 53) -1.3  (8.3) -2.2  (8.1) 5.5  (7.3)
12 h postdose (n=52, 52, 52) -1.0  (8.3) 0.8  (6.6) 5.9  (7.6)
24 h postdose (n=52, 53, 53) -1.6  (6.1) -0.8  (6.7) 3.4  (5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: 40 mg LY3009104
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares (LS) mean difference
Estimated Value 0.239
Confidence Interval (2-Sided) 90%
-1.65 to 2.12
Estimation Comments LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: 40 mg LY3009104
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.81
Confidence Interval (2-Sided) 90%
-0.0790 to 3.69
Estimation Comments LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: 40 mg LY3009104
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.44
Confidence Interval (2-Sided) 90%
-0.446 to 3.32
Estimation Comments LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: 40 mg LY3009104
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.468
Confidence Interval (2-Sided) 90%
-1.42 to 2.35
Estimation Comments LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: 40 mg LY3009104
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.702
Confidence Interval (2-Sided) 90%
-1.18 to 2.59
Estimation Comments LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: 40 mg LY3009104
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.788
Confidence Interval (2-Sided) 90%
-2.68 to 1.10
Estimation Comments LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: 40 mg LY3009104
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.71
Confidence Interval (2-Sided) 90%
-0.182 to 3.60
Estimation Comments LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: 40 mg LY3009104
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.963
Confidence Interval (2-Sided) 90%
-0.921 to 2.85
Estimation Comments LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 12.3
Confidence Interval (2-Sided) 90%
10.0 to 14.5
Estimation Comments LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 11.0
Confidence Interval (2-Sided) 90%
8.74 to 13.3
Estimation Comments LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 11.1
Confidence Interval (2-Sided) 90%
8.87 to 13.4
Estimation Comments LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.
2.Primary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104
Hide Description [Not Specified]
Time Frame Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of LY3009104.
Arm/Group Title Part A: 20 mg LY3009104 Part A: 30 mg LY3009104 Part A: 40 mg LY3009104 Part B: 40 mg LY3009104
Hide Arm/Group Description:
A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
Overall Number of Participants Analyzed 6 6 5 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomoles per liter (nmol/L)
578
(28%)
734
(14%)
1270
(13%)
741
(33%)
3.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104
Hide Description [Not Specified]
Time Frame Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of LY3009104 and had a predose and at least 1 postdose blood draw for AUC assessment.
Arm/Group Title Part A: 20 mg LY3009104 Part A: 30 mg LY3009104 Part A: 40 mg LY3009104 Part B: 40 mg LY3009104
Hide Arm/Group Description:
A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
Overall Number of Participants Analyzed 5 6 5 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours*nanomoles per liter (h*nmol/L)
3960
(27%)
5480
(19%)
8490
(14%)
6440
(26%)
4.Primary Outcome
Title Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Hide Description The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Time Frame Baseline through study completion and 30-day follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo) during the study.
Arm/Group Title Part A: Placebo Part A: 20 mg LY3009104 Part A: 30 mg LY3009104 Part A: 40 mg LY3009104 Part B: Placebo Part B: 40 mg LY3009104 Part B: Moxifloxacin
Hide Arm/Group Description:
Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
Overall Number of Participants Analyzed 8 6 6 5 52 53 53
Measure Type: Count of Participants
Unit of Measure: Participants
Drug-Related TEAE 0 0 1 0 5 5 5
Drug-Related SAE 0 0 0 0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: Placebo Part A: 20 mg LY3009104 Part A: 30 mg LY3009104 Part A: 40 mg LY3009104 Part B: Placebo Part B: 40 mg LY3009104 Part B: Moxifloxacin
Hide Arm/Group Description Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study. A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study. A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study. A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study. Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study. A 40-mg LY3009104 dose administered orally once in any period during Part B of the study. A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
All-Cause Mortality
Part A: Placebo Part A: 20 mg LY3009104 Part A: 30 mg LY3009104 Part A: 40 mg LY3009104 Part B: Placebo Part B: 40 mg LY3009104 Part B: Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part A: Placebo Part A: 20 mg LY3009104 Part A: 30 mg LY3009104 Part A: 40 mg LY3009104 Part B: Placebo Part B: 40 mg LY3009104 Part B: Moxifloxacin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/5 (0.00%)      0/52 (0.00%)      0/53 (0.00%)      0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Part A: Placebo Part A: 20 mg LY3009104 Part A: 30 mg LY3009104 Part A: 40 mg LY3009104 Part B: Placebo Part B: 40 mg LY3009104 Part B: Moxifloxacin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/8 (25.00%)      1/6 (16.67%)      2/6 (33.33%)      0/5 (0.00%)      8/52 (15.38%)      6/53 (11.32%)      7/53 (13.21%)    
Gastrointestinal disorders               
Abdominal discomfort  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/52 (1.92%)  1 0/53 (0.00%)  0 0/53 (0.00%)  0
Diarrhoea  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 3/52 (5.77%)  3 2/53 (3.77%)  2 4/53 (7.55%)  4
Dry mouth  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 1/53 (1.89%)  1 0/53 (0.00%)  0
Dyspepsia  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 1/53 (1.89%)  1 0/53 (0.00%)  0
Nausea  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/52 (1.92%)  1 0/53 (0.00%)  0 0/53 (0.00%)  0
General disorders               
Chills  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/52 (1.92%)  1 0/53 (0.00%)  0 0/53 (0.00%)  0
Fatigue  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 1/53 (1.89%)  1 0/53 (0.00%)  0
Feeling cold  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/52 (1.92%)  1 0/53 (0.00%)  0 0/53 (0.00%)  0
Infections and infestations               
Genital herpes  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Oral herpes  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Injury, poisoning and procedural complications               
Procedural site reaction  1  0/8 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 0/53 (0.00%)  0
Investigations               
Alanine aminotransferase increased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Aspartate aminotransferase increased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Blood bilirubin increased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Blood magnesium decreased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Lymphocyte count decreased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Neutrophil count decreased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Urine analysis abnormal  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 1/53 (1.89%)  1 0/53 (0.00%)  0
White blood cell count decreased  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Musculoskeletal and connective tissue disorders               
Muscle tightness  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 0/53 (0.00%)  0
Muscle twitching  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 0/53 (0.00%)  0
Musculoskeletal stiffness  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 1/53 (1.89%)  1 0/53 (0.00%)  0
Nervous system disorders               
Dizziness  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 2/52 (3.85%)  2 0/53 (0.00%)  0 0/53 (0.00%)  0
Headache  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 1/52 (1.92%)  1 2/53 (3.77%)  2 1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders               
Cough  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 1/52 (1.92%)  1 0/53 (0.00%)  0 0/53 (0.00%)  0
Increased upper airway secretion  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 0/53 (0.00%)  0
Nasal congestion  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 1/53 (1.89%)  1 0/53 (0.00%)  0
Oropharyngeal pain  1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 1/52 (1.92%)  1 0/53 (0.00%)  0 0/53 (0.00%)  0
Respiratory tract congestion  1  1/8 (12.50%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 0/53 (0.00%)  0
Skin and subcutaneous tissue disorders               
Dermatitis contact  1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 0/53 (0.00%)  0
Pruritus  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/52 (1.92%)  1 0/53 (0.00%)  0 1/53 (1.89%)  1
Rash  1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/52 (0.00%)  0 0/53 (0.00%)  0 1/53 (1.89%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01536951     History of Changes
Other Study ID Numbers: 14448
I4V-MC-JADO ( Other Identifier: Eli Lilly and Company )
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017