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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03077607
Collaborator
Medivation, Inc. (Industry)
36
Enrollment
7
Locations
2
Arms
14.4
Actual Duration (Months)
5.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study in patients with advanced solid tumors for the investigation of P-gp inhibition and induction on the PK of talazoparib.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Detailed Description

Subjects participating in this study with no clinically significant toxicities and no disease progression may be eligible to continue treatment on a separate extension protocol (MDV3800-13).

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PHASE 1 OPEN-LABEL, TWO-ARM,DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECT OF ITRACONAZOLE AND RIFAMPIN ON THE PHARMACOKINETICS OF TALAZOPARIB IN PATIENTS WITH ADVANCED SOLID TUMORS
Actual Study Start Date :
Nov 7, 2016
Actual Primary Completion Date :
Dec 19, 2017
Actual Study Completion Date :
Jan 20, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm A

Subjects will receive a 0.5 mg talazoparib and 100 mg itraconazole.

Drug: Talazoparib
Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose

Drug: Itraconazole
100 mg oral dose

Experimental: Arm B

Subjects will receive 1 mg talazoparib and 600 mg rifampin.

Drug: Talazoparib
Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose

Drug: Rifampin
600 mg oral dose

Outcome Measures

Primary Outcome Measures

  1. Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Itraconazole [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]

    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".

  2. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Itraconazole [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]

    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".

  3. Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Talazoparib: Alone and in Combination With Itraconazole [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]

    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".

  4. Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Rifampin [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]

    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".

  5. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Rifampin [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]

    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".

  6. Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Talazoparib: Alone and in Combination With Rifampin [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]

    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".

Secondary Outcome Measures

  1. Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Itraconazole [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]

    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".

  2. Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Itraconazole [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]

    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".

  3. Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Itraconazole [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]

    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".

  4. Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Itraconazole [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]

    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".

  5. Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Rifampin [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]

    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".

  6. Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Rifampin [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]

    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".

  7. Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Rifampin [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]

    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".

  8. Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Rifampin [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]

    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".

  9. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Baseline up to end of study (up to 61 days)]

    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 TEAE 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.

  10. Number of Participants With Clinical Significance Abnormalities in Laboratory Parameters [Baseline up to end of study (up to 61 days)]

    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.

  11. Number of Participants With Clinically Significant Abnormalities in Vital Signs [Baseline up to end of study (up to 61 days)]

    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.

  12. Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) [Baseline up to end of study (up to 61 days)]

    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.

  13. Number of Participants With Clinically Significant Physical Examination Findings [Baseline up to end of study (up to 61 days)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Arm A: At least 18 years of age and <65 years of age (at the time point of consent) and willing and able to provide informed consent. Arm B: At least 18 years of age (at the time point of consent) and willing and able to provide informed consent.

  2. Histologically confirmed advanced solid tumor (limited to platinum-resistant ovarian carcinoma, cervical adenocarcinoma, small cell lung carcinoma or triple-negative breast cancer) judged by the Investigator to not be appropriate for standard therapy.

  3. ECOG performance status ≤ 2 at screening and at time of enrollment.

  4. Expected life expectancy of ≥ 3 months.

  5. Able to swallow the study drug and comply with study requirements.

  6. Female subjects may be enrolled if they are considered not of childbearing potential, or who are post-menopausal, or are of childbearing potential using a highly effective form of contraceptive, and female subjects should not donate eggs from the time point of investigational medicinal product (IMP) administration until at least 45 days thereafter.

  7. Males with partners of childbearing potential may be enrolled if they use a condom when having sex with a pregnant woman or with a woman of childbearing potential, and do not donate sperm from the time point of study drug administration until at least 105 days thereafter, and males should not donate sperm from the time point of study drug administration until at least 105 days thereafter.

  8. Female subjects must not be breastfeeding at screening and during the study participation until 45 days after the last dose of the study drug.

  9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:
  1. Treatment within 14 days or 5 half lives prior to dosing with any type of systemic anticancer therapy or any investigational agent, whichever is longer

  2. Major surgery within 8 weeks before screening.

  3. Serious accompanying disorder or impaired organ function.

  4. Symptomatic or impending spinal cord compression or cauda equina syndrome.

  5. Non-healing wound, ulcer, or bone fracture, not including a pathological bone fracture caused by a pre-existent pathological bone lesion.

  6. Known myelodysplastic syndrome.

  7. Subjects with the following serologies should be excluded: HBsAg+ or anti-HBc+;HCV+; HIV+.

  8. Serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.

  9. Gastrointestinal disorder affecting absorption.

  10. Known hypersensitivity to any of the talazoparib capsule components.

  11. Any condition or reason that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Sponsor (e.g. non-compliance, excessive alcohol consumption, intake of drugs of abuse unless these drugs are medically indicated [e.g. opiates for pain relief].

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai VizsgalohelyBudapestHungary1077
2ARENSIA Exploratory Medicine Phase I Unit, PMSI Institute of OncologyChisinauMoldova, Republic ofMD2025
3Szpital LUX MEDWarsawPoland02-801
4I.M. Sechenov First Moscow State Medical UniversityMoscowRussian Federation119435
5I.M. Sechenov First Moscow State Medical UniversityMoscowRussian Federation119991
6"BioEq" LLCSaint-PetersburgRussian Federation197342
7State budget healthcare institution of Yaroslavl region "Regional clinical oncology hospital"YaroslavlRussian Federation150054

Sponsors and Collaborators

  • Pfizer
  • Medivation, Inc.

Investigators

  • Study Director: Pfizer Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03077607
Other Study ID Numbers:
  • MDV3800-04
  • C3441004
  • 2016-001813-26
First Posted:
Mar 13, 2017
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailStudy was conducted in 4 countries from 07-Nov-2016 to 18 Dec 2017.
Arm/Group TitleA: Talazoparib 0.5 mg + Itraconazole 100 mg BIDB: Talazoparib 1 mg + Rifampin 600 mg QD
Arm/Group DescriptionParticipants 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)
STARTED1917
Treated (With Any Study Drug)1917
Received Talazoparib1917
COMPLETED1717
NOT COMPLETED20
Period Title: Period 1 (15 Days)
STARTED1717
Treated (With Any Study Drug)1717
Received Talazoparib1515
COMPLETED1415
NOT COMPLETED32

Baseline Characteristics

Arm/Group TitleA: Talazoparib 0.5 mg + Itraconazole 100 mg BIDB: Talazoparib 1 mg + Rifampin 600 mg QDTotal
Arm/Group DescriptionParticipants 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 Participants191736
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
19
100%
4
23.5%
23
63.9%
>=65 years
0
0%
13
76.5%
13
36.1%
Sex: Female, Male (Count of Participants)
Female
17
89.5%
13
76.5%
30
83.3%
Male
2
10.5%
4
23.5%
6
16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
Not Hispanic or Latino
19
100%
17
100%
36
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
White
19
100%
17
100%
36
100%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleMaximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Itraconazole
DescriptionT1= 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 FrameT1=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

Outcome Measure Data

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 TitleTalazoparib 0.5 mg AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Arm/Group DescriptionParticipant 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.
Measure Participants1915
Geometric Mean (Geometric Coefficient of Variation) [Picogram per milliliter (pg/mL)]
2092.00
(50)
2936.82
(56)
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.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterGeometric LS Mean Ratio
Estimated Value139.92
Confidence Interval (2-Sided) 90%
113.26 to 172.87
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
TitleArea Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Itraconazole
DescriptionT1= 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 FrameT1=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

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group TitleTalazoparib 0.5 mg AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Arm/Group DescriptionParticipant 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.
Measure Participants1915
Geometric Mean (Geometric Coefficient of Variation) [Hour*picogram per milliliter (hr*pg/mL)]
98532.30
(38)
145944.59
(38)
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.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterGeometric LS Mean Ratio
Estimated Value150.71
Confidence Interval (2-Sided) 90%
136.47 to 166.43
Parameter Dispersion Type:
Value:
Estimation Comments
3. Primary Outcome
TitleArea Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Talazoparib: Alone and in Combination With Itraconazole
DescriptionT1= 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 FrameT1=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

Outcome Measure Data

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 TitleTalazoparib 0.5 mg AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Arm/Group DescriptionParticipant 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.
Measure Participants1812
Geometric Mean (Geometric Coefficient of Variation) [hr*pg/mL]
109762.10
(42)
151919.63
(36)
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.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterGeometric LS Mean Ratio
Estimated Value156.24
Confidence Interval (2-Sided) 90%
137.58 to 177.42
Parameter Dispersion Type:
Value:
Estimation Comments
4. Primary Outcome
TitleMaximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Rifampin
DescriptionT3= 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 FrameT3=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

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group TitleTalazoparib 1.0 mg AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants1715
Geometric Mean (Geometric Coefficient of Variation) [pg/mL]
6007.01
(53)
8336.83
(71)
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 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.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterGeometric LS Mean Ratio
Estimated Value136.62
Confidence Interval (2-Sided) 90%
103.20 to 180.87
Parameter Dispersion Type:
Value:
Estimation Comments
5. Primary Outcome
TitleArea Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Rifampin
DescriptionT3= 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 FrameT3=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

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group TitleTalazoparib 1.0 mg AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants1715
Geometric Mean (Geometric Coefficient of Variation) [hr*pg/mL]
196631.34
(32)
196100.69
(33)
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 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.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterGeometric LS Mean Ratio
Estimated Value105.37
Confidence Interval (2-Sided) 90%
98.04 to 113.24
Parameter Dispersion Type:
Value:
Estimation Comments
6. Primary Outcome
TitleArea Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Talazoparib: Alone and in Combination With Rifampin
DescriptionT3= 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 FrameT3=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

Outcome Measure Data

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 TitleTalazoparib 1.0 mg AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants1712
Geometric Mean (Geometric Coefficient of Variation) [hr*pg/mL]
209521.62
(34)
194307.67
(36)
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 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.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterGeometric LS Mean Ratio
Estimated Value102.04
Confidence Interval (2-Sided) 90%
94.02 to 110.74
Parameter Dispersion Type:
Value:
Estimation Comments
7. Secondary Outcome
TitleTime to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Itraconazole
DescriptionT1= 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 FrameT1=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

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group TitleTalazoparib 0.5 mg AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Arm/Group DescriptionParticipant 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.
Measure Participants1915
Median (Full Range) [Hours]
1.00
1.02
8. Secondary Outcome
TitleTerminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Itraconazole
DescriptionTerminal 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 FrameT1=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

Outcome Measure Data

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 TitleTalazoparib 0.5 mg AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Arm/Group DescriptionParticipant 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.
Measure Participants1812
Mean (Standard Deviation) [Hours]
101.26
(26.315)
118.47
(23.600)
9. Secondary Outcome
TitleApparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Itraconazole
DescriptionClearance 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 FrameT1=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

Outcome Measure Data

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 TitleTalazoparib 0.5 mg AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Arm/Group DescriptionParticipant 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.
Measure Participants1812
Geometric Mean (Geometric Coefficient of Variation) [Liter per hour]
4.55
(42)
3.29
(36)
10. Secondary Outcome
TitleApparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Itraconazole
DescriptionApparent 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 FrameT1=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

Outcome Measure Data

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 TitleTalazoparib 0.5 mg AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BID
Arm/Group DescriptionParticipant 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.
Measure Participants1812
Geometric Mean (Geometric Coefficient of Variation) [Liter]
644.81
(42)
552.01
(27)
11. Secondary Outcome
TitleTime to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Rifampin
DescriptionT3= 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 FrameT3=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

Outcome Measure Data

Analysis Population Description
PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.
Arm/Group TitleTalazoparib 1.0 mg AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants1715
Median (Full Range) [Hours]
1.00
1.00
12. Secondary Outcome
TitleTerminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Rifampin
DescriptionTerminal 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 FrameT3=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

Outcome Measure Data

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 TitleTalazoparib 1.0 mg AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants1712
Mean (Standard Deviation) [Hours]
92.05
(17.679)
80.61
(16.540)
13. Secondary Outcome
TitleApparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Rifampin
DescriptionApparent 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 FrameT3=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

Outcome Measure Data

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 TitleTalazoparib 1.0 mg AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants1712
Geometric Mean (Geometric Coefficient of Variation) [Liter]
623.89
(30)
588.14
(33)
14. Secondary Outcome
TitleApparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Rifampin
DescriptionClearance 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 FrameT3=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

Outcome Measure Data

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 TitleTalazoparib 1.0 mg AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants1712
Geometric Mean (Geometric Coefficient of Variation) [Liter per hour]
4.77
(34)
5.15
(36)
15. Secondary Outcome
TitleNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
DescriptionAn 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 TEAE 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 FrameBaseline up to end of study (up to 61 days)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib. Here, 1 participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
Arm/Group TitleTalazoparib 0.5 mg AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mg AloneRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants191615171715
AEs
12
63.2%
3
17.6%
5
13.9%
6
NaN
9
NaN
5
NaN
SAEs
3
15.8%
0
0%
1
2.8%
0
NaN
2
NaN
0
NaN
16. Secondary Outcome
TitleNumber of Participants With Clinical Significance Abnormalities in Laboratory Parameters
DescriptionChemistry:(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 FrameBaseline up to end of study (up to 61 days)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group TitleTalazoparib 0.5 mg AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mg AloneRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants191615171715
Count of Participants [Participants]
3
15.8%
0
0%
1
2.8%
2
NaN
1
NaN
1
NaN
17. Secondary Outcome
TitleNumber of Participants With Clinically Significant Abnormalities in Vital Signs
DescriptionVital 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 FrameBaseline up to end of study (up to 61 days)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group TitleTalazoparib 0.5 mg AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mg AloneRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants191615171715
Count of Participants [Participants]
0
0%
0
0%
1
2.8%
0
NaN
0
NaN
1
NaN
18. Secondary Outcome
TitleNumber of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
DescriptionECG 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 FrameBaseline up to end of study (up to 61 days)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group TitleTalazoparib 0.5 mg AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mg AloneRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants191615171715
Count of Participants [Participants]
0
0%
1
5.9%
0
0%
0
NaN
0
NaN
0
NaN
19. Secondary Outcome
TitleNumber of Participants With Clinically Significant Physical Examination Findings
DescriptionPhysical 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 FrameBaseline up to end of study (up to 61 days)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group TitleTalazoparib 0.5 mg AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mg AloneRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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.
Measure Participants191615171715
Count of Participants [Participants]
0
0%
0
0%
1
2.8%
1
NaN
0
NaN
0
NaN

Adverse Events

Time FrameBaseline up to end of study (up to 61 days)
Adverse Event Reporting Description One participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.
Arm/Group TitleTalazoparib 0.5 mg AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mgRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Arm/Group DescriptionParticipant 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 AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mgRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/19 (5.3%) 0/16 (0%) 1/15 (6.7%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Serious Adverse Events
Talazoparib 0.5 mg AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mgRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total3/19 (15.8%) 0/16 (0%) 1/15 (6.7%) 0/17 (0%) 2/17 (11.8%) 0/15 (0%)
Gastrointestinal disorders
Mouth haemorrhage1/19 (5.3%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Injury, poisoning and procedural complications
Anastomotic stenosis0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression2/19 (10.5%) 0/16 (0%) 1/15 (6.7%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Respiratory, thoracic and mediastinal disorders
Hydrothorax0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Other (Not Including Serious) Adverse Events
Talazoparib 0.5 mg AloneItraconazole 100 mg BID AloneTalazoparib 0.5 mg in Combination With Itraconazole 100 mg BIDTalazoparib 1.0 mgRifampin 600 mg QD AloneTalazoparib 1.0 mg in Combination With Rifampin 600 mg QD
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total12/19 (63.2%) 3/16 (18.8%) 5/15 (33.3%) 6/17 (35.3%) 9/17 (52.9%) 5/15 (33.3%)
Blood and lymphatic system disorders
Anaemia3/19 (15.8%) 0/16 (0%) 2/15 (13.3%) 2/17 (11.8%) 0/17 (0%) 0/15 (0%)
Leukopenia1/19 (5.3%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Cardiac disorders
Atrioventricular block first degree0/19 (0%) 1/16 (6.3%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Eye disorders
Conjunctivitis allergic0/19 (0%) 1/16 (6.3%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Gastrointestinal disorders
Abdominal distension1/19 (5.3%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 1/15 (6.7%)
Abdominal pain3/19 (15.8%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Constipation3/19 (15.8%) 1/16 (6.3%) 0/15 (0%) 1/17 (5.9%) 0/17 (0%) 0/15 (0%)
Dyspepsia2/19 (10.5%) 1/16 (6.3%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Gastritis1/19 (5.3%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Abdominal pain upper0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 1/17 (5.9%) 0/15 (0%)
Ascites0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Flatulence0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Gastrooesophageal reflux disease0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 1/15 (6.7%)
Nausea0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 1/17 (5.9%) 0/15 (0%)
Vomiting1/19 (5.3%) 0/16 (0%) 1/15 (6.7%) 1/17 (5.9%) 2/17 (11.8%) 0/15 (0%)
General disorders
Oedema peripheral0/19 (0%) 0/16 (0%) 1/15 (6.7%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Catheter site inflammation0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 0/17 (0%) 0/15 (0%)
Fatigue0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 2/17 (11.8%) 0/15 (0%)
Infections and infestations
Mucosal infection0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 0/17 (0%) 0/15 (0%)
Investigations
Blood alkaline phosphatase increased0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Neutrophil count decreased0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 1/15 (6.7%)
Metabolism and nutrition disorders
Decreased appetite1/19 (5.3%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Musculoskeletal and connective tissue disorders
Spinal pain1/19 (5.3%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Back pain0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 1/15 (6.7%)
Flank pain0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 0/17 (0%) 0/15 (0%)
Muscular weakness0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 0/17 (0%) 0/15 (0%)
Musculoskeletal pain0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Myalgia0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Neck pain0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Pain in extremity0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 0/17 (0%) 1/15 (6.7%)
Nervous system disorders
Headache0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 3/17 (17.6%) 1/15 (6.7%)
Paraesthesia0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 0/17 (0%) 0/15 (0%)
Renal and urinary disorders
Chromaturia0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 4/17 (23.5%) 0/15 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage1/19 (5.3%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Breast inflammation0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis2/19 (10.5%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Throat irritation1/19 (5.3%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Cough0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 1/15 (6.7%)
Dyspnoea0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Skin and subcutaneous tissue disorders
Erythema0/19 (0%) 0/16 (0%) 0/15 (0%) 1/17 (5.9%) 0/17 (0%) 0/15 (0%)
Hyperhidrosis0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 1/17 (5.9%) 0/15 (0%)
Vascular disorders
Hypertension0/19 (0%) 0/16 (0%) 1/15 (6.7%) 0/17 (0%) 0/17 (0%) 0/15 (0%)
Hypotension0/19 (0%) 0/16 (0%) 0/15 (0%) 0/17 (0%) 0/17 (0%) 1/15 (6.7%)

Limitations/Caveats

In this study 1 participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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

Name/TitlePfizer ClinicalTrials.gov Call Center
OrganizationPfizer Inc.
Phone1-800-718-1021
EmailClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03077607
Other Study ID Numbers:
  • MDV3800-04
  • C3441004
  • 2016-001813-26
First Posted:
Mar 13, 2017
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021