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A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03077607
Recruitment Status : Completed
First Posted : March 13, 2017
Results First Posted : March 29, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Solid Tumors
Interventions Drug: Talazoparib
Drug: Itraconazole
Drug: Rifampin
Enrollment 36
Recruitment Details  
Pre-assignment Details Study was conducted in 4 countries from 07-Nov-2016 to 18 Dec 2017.
Arm/Group Title A: Talazoparib 0.5 mg + Itraconazole 100 mg BID B: Talazoparib 1 mg + Rifampin 600 mg QD
Hide Arm/Group Description Participants received a single oral dose of talazoparib 0.5 milligram (mg) on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of itraconazole 200 mg (100 mg twice daily [BID]) from Day 16 to Day 36 and a single oral dose of talazoparib 0.5 mg on Day 23. Participants were followed up to 23 days after last dose of study drug. Participants received a single oral dose of talazoparib 1.0 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of rifampin 600 mg once daily (QD) from Day 16 to Day 38 and a single oral dose of talazoparib 1.0 mg on Day 25. Participants were followed up to 23 days after last dose of study drug.
Period Title: Period 1 (15 Days)
Started 19 17
Treated (With Any Study Drug) 19 17
Received Talazoparib 19 17
Completed 17 17
Not Completed 2 0
Reason Not Completed
Adverse Event             1             0
Death             1             0
Period Title: Period 2 (Arm A:21 Days; Arm B:23 Days)
Started 17 17
Treated (With Any Study Drug) 17 17
Received Talazoparib 15 15
Completed 14 15
Not Completed 3 2
Reason Not Completed
Death             1             0
Adverse Event             2             2
Arm/Group Title A: Talazoparib 0.5 mg + Itraconazole 100 mg BID B: Talazoparib 1 mg + Rifampin 600 mg QD Total
Hide Arm/Group Description Participants received a single oral dose of talazoparib 0.5 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 36 and a single oral dose of talazoparib 0.5 mg on Day 23. Participants were followed up to 23 days after last dose of study drug. Participants received a single oral dose of talazoparib 1.0 mg on Day 1, which was followed by a wash out of 14 days in Period 1. Then in Period 2 participants received oral dose of rifampin 600 mg QD from Day 16 to Day 38 and a single oral dose of talazoparib 1.0 mg on Day 25. Participants were followed up to 23 days after last dose of study drug. Total of all reporting groups
Overall Number of Baseline Participants 19 17 36
Hide Baseline Analysis Population Description
Safety population included all participants who had received at least 1 dose of talazoparib.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
4
  23.5%
23
  63.9%
>=65 years
0
   0.0%
13
  76.5%
13
  36.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Female
17
  89.5%
13
  76.5%
30
  83.3%
Male
2
  10.5%
4
  23.5%
6
  16.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
19
 100.0%
17
 100.0%
36
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
19
 100.0%
17
 100.0%
36
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Itraconazole
Hide Description T1= Time frame for “Talazoparib 0.5 mg Alone” and T2= time frame for “Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID”.
Time Frame T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group Title Talazoparib 0.5 mg Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Overall Number of Participants Analyzed 19 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picogram per milliliter (pg/mL)
2092.00
(50%)
2936.82
(56%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib 0.5 mg Alone, Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Comments Confidence interval (CI): 90 percent (%) CI on geometric least squares (LS) mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using analysis of variance (ANOVA)
Type of Statistical Test Equivalence
Comments Sample size of 15 participants was selected based on the estimated within participant % coefficient of variation (CV) of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.
Method of Estimation Estimation Parameter Geometric LS Mean Ratio
Estimated Value 139.92
Confidence Interval (2-Sided) 90%
113.26 to 172.87
Estimation Comments [Not Specified]
2.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Itraconazole
Hide Description T1= Time frame for “Talazoparib 0.5 mg Alone” and T2= time frame for “Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID”.
Time Frame T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group Title Talazoparib 0.5 mg Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Overall Number of Participants Analyzed 19 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*picogram per milliliter (hr*pg/mL)
98532.30
(38%)
145944.59
(38%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib 0.5 mg Alone, Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Comments CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.
Type of Statistical Test Equivalence
Comments Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.
Method of Estimation Estimation Parameter Geometric LS Mean Ratio
Estimated Value 150.71
Confidence Interval (2-Sided) 90%
136.47 to 166.43
Estimation Comments [Not Specified]
3.Primary Outcome
Title Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Talazoparib: Alone and in Combination With Itraconazole
Hide Description T1= Time frame for “Talazoparib 0.5 mg Alone” and T2= time frame for “Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID”.
Time Frame T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, “Overall number of participants analyzed" (N) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Talazoparib 0.5 mg Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Overall Number of Participants Analyzed 18 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
109762.10
(42%)
151919.63
(36%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib 0.5 mg Alone, Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Comments CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.
Type of Statistical Test Equivalence
Comments Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.
Method of Estimation Estimation Parameter Geometric LS Mean Ratio
Estimated Value 156.24
Confidence Interval (2-Sided) 90%
137.58 to 177.42
Estimation Comments [Not Specified]
4.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Rifampin
Hide Description T3= Time frame for “Talazoparib 1.0 mg Alone” and T4= time frame for “Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD”.
Time Frame T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group Title Talazoparib 1.0 mg Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 17 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
6007.01
(53%)
8336.83
(71%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib 1.0 mg Alone, Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Comments CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.
Type of Statistical Test Equivalence
Comments Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.
Method of Estimation Estimation Parameter Geometric LS Mean Ratio
Estimated Value 136.62
Confidence Interval (2-Sided) 90%
103.20 to 180.87
Estimation Comments [Not Specified]
5.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Rifampin
Hide Description T3= Time frame for “Talazoparib 1.0 mg Alone” and T4= time frame for “Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD”.
Time Frame T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group Title Talazoparib 1.0 mg Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 17 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
196631.34
(32%)
196100.69
(33%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib 1.0 mg Alone, Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Comments CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.
Type of Statistical Test Equivalence
Comments Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.
Method of Estimation Estimation Parameter Geometric LS Mean Ratio
Estimated Value 105.37
Confidence Interval (2-Sided) 90%
98.04 to 113.24
Estimation Comments [Not Specified]
6.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Talazoparib: Alone and in Combination With Rifampin
Hide Description T3= Time frame for “Talazoparib 1.0 mg Alone” and T4= time frame for “Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD”.
Time Frame T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Talazoparib 1.0 mg Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 17 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*pg/mL
209521.62
(34%)
194307.67
(36%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib 1.0 mg Alone, Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Comments CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.
Type of Statistical Test Equivalence
Comments Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.
Method of Estimation Estimation Parameter Geometric LS Mean Ratio
Estimated Value 102.04
Confidence Interval (2-Sided) 90%
94.02 to 110.74
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Itraconazole
Hide Description T1= Time frame for “Talazoparib 0.5 mg Alone” and T2= time frame for “Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID”.
Time Frame T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group Title Talazoparib 0.5 mg Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Overall Number of Participants Analyzed 19 15
Median (Full Range)
Unit of Measure: Hours
1.00
(0.5 to 24.1)
1.02
(0.5 to 4.0)
8.Secondary Outcome
Title Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Itraconazole
Hide Description Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half. T1= Time frame for “Talazoparib 0.5 mg Alone” and T2= time frame for “Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID”.
Time Frame T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Talazoparib 0.5 mg Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Overall Number of Participants Analyzed 18 12
Mean (Standard Deviation)
Unit of Measure: Hours
101.26  (26.315) 118.47  (23.600)
9.Secondary Outcome
Title Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Itraconazole
Hide Description Clearance of talazoparib was measure of the rate at which it was metabolized or eliminated by normal biological processes. T1= Time frame for “Talazoparib 0.5 mg Alone” and T2= time frame for “Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID”.
Time Frame T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Talazoparib 0.5 mg Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Overall Number of Participants Analyzed 18 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter per hour
4.55
(42%)
3.29
(36%)
10.Secondary Outcome
Title Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Itraconazole
Hide Description Apparent volume of distribution was defined as the theoretical volume in which the total amount of talazoparib would need to be uniformly distributed to produce its desired plasma concentration. T1= Time frame for “Talazoparib 0.5 mg Alone” and T2= time frame for “Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID”.
Time Frame T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Talazoparib 0.5 mg Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Overall Number of Participants Analyzed 18 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
644.81
(42%)
552.01
(27%)
11.Secondary Outcome
Title Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Rifampin
Hide Description T3= Time frame for “Talazoparib 1.0 mg Alone” and T4= time frame for “Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD”.
Time Frame T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group Title Talazoparib 1.0 mg Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 17 15
Median (Full Range)
Unit of Measure: Hours
1.00
(0.5 to 24.0)
1.00
(0.5 to 8.0)
12.Secondary Outcome
Title Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Rifampin
Hide Description Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half. T3= Time frame for “Talazoparib 1.0 mg Alone” and T4= time frame for “Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD”.
Time Frame T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Talazoparib 1.0 mg Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Hours
92.05  (17.679) 80.61  (16.540)
13.Secondary Outcome
Title Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Rifampin
Hide Description Apparent volume of distribution was defined as the theoretical volume in which the total amount of talazoparib would need to be uniformly distributed to produce its desired plasma concentration. T3= Time frame for “Talazoparib 1.0 mg Alone” and T4= time frame for “Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD”.
Time Frame T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Talazoparib 1.0 mg Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 17 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
623.89
(30%)
588.14
(33%)
14.Secondary Outcome
Title Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Rifampin
Hide Description Clearance of talazoparib was measure of the rate at which it was metabolized or eliminated by normal biological processes. T3= Time frame for “Talazoparib 1.0 mg Alone” and T4= time frame for “Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD”.
Time Frame T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Talazoparib 1.0 mg Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 17 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter per hour
4.77
(34%)
5.15
(36%)
15.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs included both serious and non-serious adverse events.
Time Frame Baseline up to end of study (up to 61 days)
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Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Alone Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 19 16 15 17 16 15
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
12
  63.2%
3
  18.8%
5
  33.3%
7
  41.2%
8
  50.0%
5
  33.3%
SAEs
3
  15.8%
0
   0.0%
1
   6.7%
1
   5.9%
1
   6.3%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Clinical Significance Abnormalities in Laboratory Parameters
Hide Description Chemistry:(sodium135-146,potassium3.5-5.5,chloride95-109,glucose3.3-5.5,urea2.8-7.2,calcium2.2-2.65,phosphate0.8-1.45,triglyceride0.4-1.7,cholesterol2.6-5.2)millimoles/L, (bilirubin[direct0-3,total2-21],creatinine53- 110)micromole/L, (albumin35-52,protein65-83)g/L,(alkaline phosphatase30-120, aspartate amino[A]transferase[T]4-46, alanine AT4-49, lactic acid dehydrogenase200-460, gammaglutamylT7-50,creatinine kinase24-170)U/L. Hematology: hemoglobin(Hb)120-177, hematocrit0.35-0.49L/L, RBC4-5.9T/L, (platelet150- 400,WBC4-10,basophil<0.10,eosinophil<0.40, neutrophil1.50-7.00,monocyte<1.20,lymphocyte1.0 -3.70)G/L. Urine:(glucose,protein,ketone,Hb:negative/positive), specific gravity1.010-1.030g/cm^3, pH4.8-7.8, pale yellow-deep amber, microscopy[WBC0-5,leukocyte0-5,Hb0-3,cast0-1,bacteria0-500,epithelial0-6])Pcs/area. Coagulation:(activated partial thromboplastine time25-43,prothrombin time13.7-15.6) seconds,international normalized ratio0.89-1.1. Investigator judged clinical significance.
Time Frame Baseline up to end of study (up to 61 days)
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Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Alone Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 19 16 15 17 16 15
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.8%
0
   0.0%
1
   6.7%
2
  11.8%
1
   6.3%
1
   6.7%
17.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Vital Signs
Hide Description Vital sign abnormalities: a) systolic blood pressure (SBP): 1) minimum less than (<) 90 millimeter of mercury (mmHg), 2) change from baseline maximum decrease greater than equal to (>=) 30 mmHg, 3) change from baseline maximum increase >=30 mmHg; b) diastolic blood pressure (DBP): 1) minimum <50 mmHg, 2) change from baseline maximum decrease >=20 mmHg, 3) change from baseline maximum increase >=20 mmHg; c) supine pulse rate: 1) minimum <40 beats per minute (bpm), 2) maximum >120 bpm; d) standing pulse rate: 1) minimum <40 bpm and 2) maximum >140 bpm. Clinical significance of vital signs abnormalities was judged by investigator.
Time Frame Baseline up to end of study (up to 61 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Alone Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 19 16 15 17 16 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
1
   6.7%
18.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Hide Description ECG abnormalities: a) QT Interval: new absolute values greater than (>) 450, >480, >500 milliseconds (msec), increase from baseline >30 and >60 msec, b) QT interval using Fridericia’s correction (QTcF) Interval: new absolute values >450, >480, >500 msec, increase from baseline >30 and > 60 msec, c) Heart rate: increase from baseline >25 percentage (%) and to a value >100 bpm, decrease from baseline >25% and to a value <50 bpm, d) PR Interval: increase from baseline > 25% and to a value >200 msec, e) QRS duration: increase from baseline > 25% and to a value >100 msec. Clinical significance of ECG abnormalities was judged by investigator.
Time Frame Baseline up to end of study (up to 61 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Alone Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 19 16 15 17 16 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Participants With Clinically Significant Physical Examination Findings
Hide Description Physical examination included examination of abdomen, cardiovascular, eyes, ears, nose, throat, general appearance, head, neck, thyroid, lymph nodes, musculoskeletal, neurological, skin / subcutaneous tissue, thorax / lungs, abdomen including spleen size, breasts (female only) and respiratory. Clinical significance of physical examination was judged by investigator.
Time Frame Baseline up to end of study (up to 61 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Alone Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description:
Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2.
Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2.
Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1.
Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2.
Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
Overall Number of Participants Analyzed 19 16 15 17 16 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   6.7%
1
   5.9%
0
   0.0%
0
   0.0%
Time Frame Baseline up to end of study (up to 61 days)
Adverse Event Reporting Description Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who had received at least 1 dose of talazoparib.
 
Arm/Group Title Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Hide Arm/Group Description Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2. Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1. Participants those who had received a single oral dose of talazoparib 1.0 mg on Day 1 in Period 1, received oral dose of rifampin 600 mg QD from Day 16 to Day 24 in Period 2. Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2.
All-Cause Mortality
Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)   0/16 (0.00%)   1/15 (6.67%)   0/17 (0.00%)   0/16 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/19 (15.79%)   0/16 (0.00%)   1/15 (6.67%)   1/17 (5.88%)   1/16 (6.25%)   0/15 (0.00%) 
Gastrointestinal disorders             
Mouth haemorrhage * 1  1/19 (5.26%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Injury, poisoning and procedural complications             
Anastomotic stenosis * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/15 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Neoplasm progression * 1  2/19 (10.53%)  0/16 (0.00%)  1/15 (6.67%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Hydrothorax * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Talazoparib 0.5 mg Alone Itraconazole 100 mg BID Alone Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID Talazoparib 1.0 mg Rifampin 600 mg QD Alone Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/19 (63.16%)   3/16 (18.75%)   5/15 (33.33%)   6/17 (35.29%)   8/16 (50.00%)   5/15 (33.33%) 
Blood and lymphatic system disorders             
Anaemia * 1  3/19 (15.79%)  0/16 (0.00%)  2/15 (13.33%)  2/17 (11.76%)  0/16 (0.00%)  0/15 (0.00%) 
Leukopenia * 1  1/19 (5.26%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Cardiac disorders             
Atrioventricular block first degree * 1  0/19 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Eye disorders             
Conjunctivitis allergic * 1  0/19 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Gastrointestinal disorders             
Abdominal distension * 1  1/19 (5.26%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  1/15 (6.67%) 
Abdominal pain * 1  3/19 (15.79%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Constipation * 1  3/19 (15.79%)  1/16 (6.25%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/15 (0.00%) 
Dyspepsia * 1  2/19 (10.53%)  1/16 (6.25%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Gastritis * 1  1/19 (5.26%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Abdominal pain upper * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  1/16 (6.25%)  0/15 (0.00%) 
Ascites * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Flatulence * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Gastrooesophageal reflux disease * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Nausea * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  1/16 (6.25%)  0/15 (0.00%) 
Vomiting * 1  1/19 (5.26%)  0/16 (0.00%)  1/15 (6.67%)  1/17 (5.88%)  2/16 (12.50%)  0/15 (0.00%) 
General disorders             
Oedema peripheral * 1  0/19 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Catheter site inflammation * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/15 (0.00%) 
Fatigue * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  2/16 (12.50%)  0/15 (0.00%) 
Infections and infestations             
Mucosal infection * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/15 (0.00%) 
Investigations             
Blood alkaline phosphatase increased * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Neutrophil count decreased * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Metabolism and nutrition disorders             
Decreased appetite * 1  1/19 (5.26%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders             
Spinal pain * 1  1/19 (5.26%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Back pain * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Flank pain * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/15 (0.00%) 
Muscular weakness * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/15 (0.00%) 
Musculoskeletal pain * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Myalgia * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Neck pain * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Pain in extremity * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  1/15 (6.67%) 
Nervous system disorders             
Headache * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  3/16 (18.75%)  1/15 (6.67%) 
Paraesthesia * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/15 (0.00%) 
Renal and urinary disorders             
Chromaturia * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  4/16 (25.00%)  0/15 (0.00%) 
Reproductive system and breast disorders             
Vaginal haemorrhage * 1  1/19 (5.26%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Breast inflammation * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Epistaxis * 1  2/19 (10.53%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Throat irritation * 1  1/19 (5.26%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Cough * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Dyspnoea * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders             
Erythema * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/15 (0.00%) 
Hyperhidrosis * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Vascular disorders             
Hypertension * 1  0/19 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  0/17 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Hypotension * 1  0/19 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03077607     History of Changes
Other Study ID Numbers: MDV3800-04
C3441004 ( Other Identifier: Alias Study Number )
2016-001813-26 ( EudraCT Number )
First Submitted: January 20, 2017
First Posted: March 13, 2017
Results First Submitted: December 18, 2018
Results First Posted: March 29, 2019
Last Update Posted: July 2, 2019