Trial Outcomes & Findings for An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) (NCT NCT02997176)

Last Updated: 2021-02-25

Results Overview

AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

38 participants

Primary outcome timeframe

Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Results posted on

2021-02-25

Participant Flow

Participants with advanced solid tumors and impaired hepatic function were enrolled. Participants were assigned to 1 of the 4 groups based on their hepatic function as per the national cancer institute organ dysfunction working group (NCI-ODWG) classification.

Participant milestones

Participant milestones
Measure	Talazoparib: Normal Hepatic Function Participants with total bilirubin (TB) and aspartate aminotransferase (AST) less than or equal to (\<=) upper limit of normal (ULN), received talazoparib 0.5 milligram (mg) (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Mild Hepatic Impairment Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Overall Study STARTED	7	10	5	16
Overall Study COMPLETED	6	8	3	5
Overall Study NOT COMPLETED	1	2	2	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Talazoparib: Normal Hepatic Function Participants with total bilirubin (TB) and aspartate aminotransferase (AST) less than or equal to (\<=) upper limit of normal (ULN), received talazoparib 0.5 milligram (mg) (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Mild Hepatic Impairment Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Overall Study Adverse Event	0	0	0	8
Overall Study Progressive Disease	1	0	1	1
Overall Study Death	0	0	1	1
Overall Study Withdrawal by Subject	0	2	0	1

Baseline Characteristics

An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Total n=38 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 7.61 • n=5 Participants	56.6 years STANDARD_DEVIATION 17.08 • n=7 Participants	60.4 years STANDARD_DEVIATION 6.31 • n=5 Participants	52.7 years STANDARD_DEVIATION 11.98 • n=4 Participants	56.1 years STANDARD_DEVIATION 12.40 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants	26 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants	28 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants	31 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Population: Pharmacokinetic (PK) evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.

AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=6 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 22	111.8 nanogram*hour per milliliter Geometric Coefficient of Variation 30	159.0 nanogram*hour per milliliter Geometric Coefficient of Variation 99	123.6 nanogram*hour per milliliter Geometric Coefficient of Variation 30	NA nanogram*hour per milliliter Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

PRIMARY outcome

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Population: PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.

Cmax was defined as the maximum observed plasma concentration of talazoparib.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=6 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 22	10.30 nanogram per milliliter Geometric Coefficient of Variation 23	11.30 nanogram per milliliter Geometric Coefficient of Variation 65	13.56 nanogram per milliliter Geometric Coefficient of Variation 23	NA nanogram per milliliter Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

PRIMARY outcome

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu\*AUC0-24. fu= Fraction of Unbound (fu) Plasma.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=6 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 22	30.17 nanogram*hour per milliliter Geometric Coefficient of Variation 11	45.08 nanogram*hour per milliliter Geometric Coefficient of Variation 84	33.50 nanogram*hour per milliliter Geometric Coefficient of Variation 35	NA nanogram*hour per milliliter Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

PRIMARY outcome

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu\*Cmax.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=6 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 22	2.778 nanogram per milliliter Geometric Coefficient of Variation 27	3.204 nanogram per milliliter Geometric Coefficient of Variation 56	3.675 nanogram per milliliter Geometric Coefficient of Variation 28	NA nanogram per milliliter Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1

Population: PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=8 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=13 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 1	22.21 nanogram*hour per milliliter Geometric Coefficient of Variation 41	27.63 nanogram*hour per milliliter Geometric Coefficient of Variation 38	25.20 nanogram*hour per milliliter Geometric Coefficient of Variation 7	21.26 nanogram*hour per milliliter Geometric Coefficient of Variation 58

SECONDARY outcome

Timeframe: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1

Cmax was defined as the maximum observed plasma concentration of talazoparib.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=8 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=15 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 1	3.068 nanogram per milliliter Geometric Coefficient of Variation 66	3.047 nanogram per milliliter Geometric Coefficient of Variation 32	2.959 nanogram per milliliter Geometric Coefficient of Variation 44	1.965 nanogram per milliliter Geometric Coefficient of Variation 90

SECONDARY outcome

Timeframe: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1

Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=8 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=15 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 1	1.00 hour Interval 0.5 to 1.02	1.51 hour Interval 0.5 to 2.05	0.55 hour Interval 0.48 to 1.02	1.00 hour Interval 0.5 to 24.62

SECONDARY outcome

Timeframe: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1

Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=9 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=14 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Fraction of Unbound (fu) Plasma Talazoparib on Day 1	28.76 percentage of drug concentration Geometric Coefficient of Variation 20	28.11 percentage of drug concentration Geometric Coefficient of Variation 14	27.47 percentage of drug concentration Geometric Coefficient of Variation 15	34.66 percentage of drug concentration Geometric Coefficient of Variation 17

SECONDARY outcome

Timeframe: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1

AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu\*AUC0-24.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=8 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=11 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 1	6.388 nanogram*hour per milliliter Geometric Coefficient of Variation 42	7.569 nanogram*hour per milliliter Geometric Coefficient of Variation 35	6.922 nanogram*hour per milliliter Geometric Coefficient of Variation 14	7.528 nanogram*hour per milliliter Geometric Coefficient of Variation 51

SECONDARY outcome

Timeframe: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1

Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu\*Cmax

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=8 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=13 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 1	0.8823 nanogram per milliliter Geometric Coefficient of Variation 76	0.8345 nanogram per milliliter Geometric Coefficient of Variation 35	0.8131 nanogram per milliliter Geometric Coefficient of Variation 40	0.7448 nanogram per milliliter Geometric Coefficient of Variation 78

SECONDARY outcome

Timeframe: Pre-dose on Day 8, 15 and 22

Population: Analysis population for this outcome measure included those participants who met acceptance criteria for Ctrough. Here 'number analyzed' signifies number of participants evaluable for each specified row.

Ctrough was defined as plasma trough (pre-dose) concentration of talazoparib. Acceptance criteria for Ctrough on Day 15 and Day 22: received 10 consecutive days of dosing immediately before PK sampling day; Sample drawn within 24 +/-2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day. Ctrough on Day 8: received 7 consecutive days of dosing immediately before PK sampling day; sample drawn within 24 +/- 2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=6 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=4 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Plasma Trough Concentration (Ctrough) of Talazoparib on Day 8, 15 and 22 Day 8	2.244 nanogram per milliliter Geometric Coefficient of Variation 22	4.807 nanogram per milliliter Geometric Coefficient of Variation 93	3.788 nanogram per milliliter Geometric Coefficient of Variation 80	3.329 nanogram per milliliter Geometric Coefficient of Variation 57
Plasma Trough Concentration (Ctrough) of Talazoparib on Day 8, 15 and 22 Day 15	2.857 nanogram per milliliter Geometric Coefficient of Variation 39	NA nanogram per milliliter Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.	2.909 nanogram per milliliter Geometric Coefficient of Variation 3	4.208 nanogram per milliliter Geometric Coefficient of Variation 86
Plasma Trough Concentration (Ctrough) of Talazoparib on Day 8, 15 and 22 Day 22	2.624 nanogram per milliliter Geometric Coefficient of Variation 28	3.699 nanogram per milliliter Geometric Coefficient of Variation 197	3.553 nanogram per milliliter Geometric Coefficient of Variation 8	NA nanogram per milliliter Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=6 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 22	1.50 hour Interval 0.5 to 2.13	2.13 hour Interval 1.05 to 4.0	1.05 hour Interval 1.0 to 2.75	NA hour Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Population: Analysis population included participants with available data.

Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=8 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=5 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Fraction of Unbound (fu) Plasma Talazoparib on Day 22	26.98 percentage of drug concentration Geometric Coefficient of Variation 23	27.71 percentage of drug concentration Geometric Coefficient of Variation 18	27.10 percentage of drug concentration Geometric Coefficient of Variation 9	33.92 percentage of drug concentration Geometric Coefficient of Variation 25

SECONDARY outcome

Timeframe: Pre-dose (within 60 minutes prior to dose) on Day 1, pre-dose(24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose) on Day 22 and 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Days 1 and 22

Population: PK evaluable analysis population was analyzed. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.

Accumulation ratio for AUC0-24 was calculated as area under the curve from time zero to 24 hours on Day 22 divided by area under the curve from time zero to 24 hours on Day 1.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=5 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=1 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Accumulation Ratio (Rac) of Plasma Talazoparib	5.070 ratio Geometric Coefficient of Variation 24	5.134 ratio Geometric Coefficient of Variation 68	4.771 ratio Geometric Coefficient of Variation 31	NA ratio Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Talazoparib clearance is a measure of the rate at which talazoparib is metabolized or eliminated by normal biological processes.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=6 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Apparent Clearance (CL/F) of Plasma Talazoparib on Day 22	5.070 liter per hour Geometric Coefficient of Variation 24	5.134 liter per hour Geometric Coefficient of Variation 68	4.771 liter per hour Geometric Coefficient of Variation 31	NA liter per hour Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22

Clearance of unbound talazoparib is a measure of the rate at which unbound talazoparib is metabolized or eliminated by normal biological processes.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=6 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Unbound Apparent Clearance (CLu/F) of PlasmaTalazoparib on Day 22	16.57 liter per hour Geometric Coefficient of Variation 11	11.09 liter per hour Geometric Coefficient of Variation 84	14.92 liter per hour Geometric Coefficient of Variation 35	NA liter per hour Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: A single void at pre-dose, post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 1

Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=8 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=4 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=8 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 1	0.03816 milligram Geometric Coefficient of Variation 79	0.03534 milligram Geometric Coefficient of Variation 71	0.04292 milligram Geometric Coefficient of Variation 85	0.02319 milligram Geometric Coefficient of Variation 107

SECONDARY outcome

Timeframe: A single void at pre-dose, post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 1

Ae0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=8 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=4 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=8 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Percentage of Talazoparib Excreted in Urine From Time Zero to 24 Hours (Ae 0-24%) on Day 1	7.638 percentage of dose Geometric Coefficient of Variation 79	7.070 percentage of dose Geometric Coefficient of Variation 71	8.582 percentage of dose Geometric Coefficient of Variation 85	4.641 percentage of dose Geometric Coefficient of Variation 107

SECONDARY outcome

Timeframe: Urine voided post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 22

Population: PK evaluable analysis population was analyzed. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.

Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=5 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 22	0.2229 milligram Geometric Coefficient of Variation 30	0.1819 milligram Geometric Coefficient of Variation 34	0.1867 milligram Geometric Coefficient of Variation 32	NA milligram Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: Urine voided post-dose at any time between 0 to 12 and any time between 12 to 24 hours (hrs) on Day 22

Population: PK evaluable analysis population was analyzed. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.

Ae 0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=5 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) on Day 22	44.58 percentage of dose Geometric Coefficient of Variation 30	36.36 percentage of dose Geometric Coefficient of Variation 34	37.40 percentage of dose Geometric Coefficient of Variation 31	NA percentage of dose Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: Ae: Post-dose at any time between 0 to 12, 12 to 24 hrs on Day 22; AUC0-24: Pre-dose (24 hrs +/- 60 minutes from previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, any time between 8 to12, 24 hrs post-dose on Day 22

Population: PK evaluable analysis population was analyzed. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure.

Renal clearance was calculated as cumulative amount of drug excreted in urine during the 24 hours dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to 24 hours post dose (AUC0-24).

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=6 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=5 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=3 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=2 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Renal Clearance (CLr) of Talazoparib on Day 22	1.993 liters per hour Geometric Coefficient of Variation 57	1.449 liters per hour Geometric Coefficient of Variation 92	1.510 liters per hour Geometric Coefficient of Variation 39	NA liters per hour Geometric Coefficient of Variation NA Data is not reported, as it was planned to report statistics when there were \>=3 evaluable participants.

SECONDARY outcome

Timeframe: Baseline up to 30 days after last dose of study drug (up to 52 days)

Population: Safety analysis set included all participants who received any amount of talazoparib.

Clinically significant laboratory abnormalities included aspartate transaminase (AST) or alanine aminotransferase (ALT) \>=3 times ULN (\>5 \*ULN if baseline ALT/AST is \>3 \*ULN) and total bilirubin (TBL) \>2 times ULN or INR \>1.5, AST or ALT \>=3 times ULN with signs and symptoms consistent with hepatitis and/or eosinophilia (\>=500 eosinophils/microliter).

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Number of Participants With Clinically Significant Laboratory Abnormalities	0 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Day 2, 8, 15, 22 and End of Study (Day 52)

Population: Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.

Systolic blood pressure and diastolic blood pressure were evaluated for examination of vital signs.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Systolic Blood Pressure: Baseline	128.1 millimeter of mercury (mmHg) Standard Deviation 19.22	110.3 millimeter of mercury (mmHg) Standard Deviation 11.84	121.8 millimeter of mercury (mmHg) Standard Deviation 23.15	115.8 millimeter of mercury (mmHg) Standard Deviation 13.57
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Systolic Blood Pressure: Change at Day 2	-12.3 millimeter of mercury (mmHg) Standard Deviation 17.72	-1.1 millimeter of mercury (mmHg) Standard Deviation 12.86	-12.5 millimeter of mercury (mmHg) Standard Deviation 14.48	2.2 millimeter of mercury (mmHg) Standard Deviation 10.43
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Systolic Blood Pressure: Change at Day 8	-2.0 millimeter of mercury (mmHg) Standard Deviation 20.22	-2.8 millimeter of mercury (mmHg) Standard Deviation 9.85	-5.6 millimeter of mercury (mmHg) Standard Deviation 11.97	-5.3 millimeter of mercury (mmHg) Standard Deviation 10.80
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Systolic Blood Pressure: Change at Day 15	-8.4 millimeter of mercury (mmHg) Standard Deviation 8.64	0.3 millimeter of mercury (mmHg) Standard Deviation 12.08	-6.0 millimeter of mercury (mmHg) Standard Deviation 23.47	-2.3 millimeter of mercury (mmHg) Standard Deviation 13.91
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Systolic Blood Pressure: Change at Day 22	-7.5 millimeter of mercury (mmHg) Standard Deviation 15.10	-4.3 millimeter of mercury (mmHg) Standard Deviation 14.30	-10.7 millimeter of mercury (mmHg) Standard Deviation 32.56	-7.8 millimeter of mercury (mmHg) Standard Deviation 17.20
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Systolic Blood Pressure: Change at end of study (Day 52)	-0.8 millimeter of mercury (mmHg) Standard Deviation 18.36	0.7 millimeter of mercury (mmHg) Standard Deviation 14.22	—	-26.0 millimeter of mercury (mmHg)
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Diastolic Blood Pressure: Baseline	75.9 millimeter of mercury (mmHg) Standard Deviation 12.52	65.9 millimeter of mercury (mmHg) Standard Deviation 10.77	68.4 millimeter of mercury (mmHg) Standard Deviation 5.59	73.9 millimeter of mercury (mmHg) Standard Deviation 10.60
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Diastolic Blood Pressure: Change at Day 2	-5.0 millimeter of mercury (mmHg) Standard Deviation 6.76	4.1 millimeter of mercury (mmHg) Standard Deviation 7.69	-4.5 millimeter of mercury (mmHg) Standard Deviation 6.19	-0.8 millimeter of mercury (mmHg) Standard Deviation 7.03
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Diastolic Blood Pressure: Change at Day 8	-1.0 millimeter of mercury (mmHg) Standard Deviation 12.04	4.1 millimeter of mercury (mmHg) Standard Deviation 6.66	-0.8 millimeter of mercury (mmHg) Standard Deviation 9.12	-4.1 millimeter of mercury (mmHg) Standard Deviation 9.91
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Diastolic Blood Pressure: Change at Day 15	-1.4 millimeter of mercury (mmHg) Standard Deviation 6.92	0.9 millimeter of mercury (mmHg) Standard Deviation 9.00	0.8 millimeter of mercury (mmHg) Standard Deviation 10.84	-2.1 millimeter of mercury (mmHg) Standard Deviation 4.97
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Diastolic Blood Pressure: Change at Day 22	-3.5 millimeter of mercury (mmHg) Standard Deviation 9.14	-3.0 millimeter of mercury (mmHg) Standard Deviation 7.82	-3.3 millimeter of mercury (mmHg) Standard Deviation 15.53	-6.0 millimeter of mercury (mmHg) Standard Deviation 11.17
Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study Diastolic Blood Pressure: Change at end of study (Day 52)	-0.3 millimeter of mercury (mmHg) Standard Deviation 8.26	1.9 millimeter of mercury (mmHg) Standard Deviation 7.52	—	-17.0 millimeter of mercury (mmHg)

SECONDARY outcome

Timeframe: Baseline, Day 2, 8, 15, 22 and End of Study (Day 52)

Population: Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.

Heart rate was measured in beats per minute.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study Baseline	75.9 beats per minute Standard Deviation 7.67	89.2 beats per minute Standard Deviation 19.34	87.4 beats per minute Standard Deviation 22.13	92.3 beats per minute Standard Deviation 16.76
Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study Change at Day 2	3.0 beats per minute Standard Deviation 7.64	4.7 beats per minute Standard Deviation 10.01	1.0 beats per minute Standard Deviation 6.16	1.4 beats per minute Standard Deviation 11.01
Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study Change at Day 8	1.7 beats per minute Standard Deviation 7.78	3.5 beats per minute Standard Deviation 16.10	1.6 beats per minute Standard Deviation 4.67	-2.7 beats per minute Standard Deviation 8.79
Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study Change at Day 15	5.1 beats per minute Standard Deviation 9.82	-6.0 beats per minute Standard Deviation 12.76	2.5 beats per minute Standard Deviation 7.05	3.8 beats per minute Standard Deviation 15.52
Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study Change at Day 22	2.2 beats per minute Standard Deviation 9.81	-9.9 beats per minute Standard Deviation 20.38	-2.0 beats per minute Standard Deviation 1.00	2.3 beats per minute Standard Deviation 19.16
Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study Change at end of study (Day 52)	8.5 beats per minute Standard Deviation 11.90	3.1 beats per minute Standard Deviation 15.56	—	23.0 beats per minute

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and End of Study (Day 52)

Population: Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.

Respiratory rate was measured in terms of breaths per minute.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study Change at Day 22	-0.2 breaths per minute Standard Deviation 0.98	-0.6 breaths per minute Standard Deviation 1.41	1.3 breaths per minute Standard Deviation 0.58	1.1 breaths per minute Standard Deviation 1.17
Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study Baseline	18.3 breaths per minute Standard Deviation 2.63	17.1 breaths per minute Standard Deviation 1.20	16.8 breaths per minute Standard Deviation 0.84	17.4 breaths per minute Standard Deviation 1.63
Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study Change at Day 8	-0.3 breaths per minute Standard Deviation 2.06	0.6 breaths per minute Standard Deviation 1.77	1.2 breaths per minute Standard Deviation 2.39	-0.1 breaths per minute Standard Deviation 2.19
Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study Change at Day 15	-1.6 breaths per minute Standard Deviation 3.15	-0.4 breaths per minute Standard Deviation 1.51	0.3 breaths per minute Standard Deviation 1.53	0.4 breaths per minute Standard Deviation 1.51
Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study Change at end of study (Day 52)	-0.5 breaths per minute Standard Deviation 1.00	0.1 breaths per minute Standard Deviation 1.46	—	2.0 breaths per minute

SECONDARY outcome

Timeframe: Baseline, Day 8, 15, 22 and End of Study (Day 52)

Population: Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study Baseline	82.01 kilogram Standard Deviation 15.749	63.07 kilogram Standard Deviation 11.493	77.78 kilogram Standard Deviation 17.070	66.98 kilogram Standard Deviation 12.979
Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study Change at Day 8	-0.04 kilogram Standard Deviation 0.943	-0.10 kilogram Standard Deviation 1.865	-2.02 kilogram Standard Deviation 1.656	-1.50 kilogram Standard Deviation 3.728
Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study Change at Day 15	-0.36 kilogram Standard Deviation 0.621	-0.09 kilogram Standard Deviation 2.119	-1.78 kilogram Standard Deviation 0.900	-1.29 kilogram Standard Deviation 5.025
Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study Change at Day 22	-0.78 kilogram Standard Deviation 0.546	0.28 kilogram Standard Deviation 1.647	-1.57 kilogram Standard Deviation 0.462	-2.06 kilogram Standard Deviation 5.416
Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study Change at end of study (Day 52)	0.48 kilogram Standard Deviation 1.839	1.81 kilogram Standard Deviation 1.577	—	0.90 kilogram

SECONDARY outcome

Timeframe: Baseline up to 30 days after last dose of study drug (up to 52 days)

Population: Safety analysis set included all participants who received any amount of talazoparib.

Pre-specified 12-Lead electrocardiogram (ECG) Criteria: QTCF (Fridericia's correction formula) : \>=450 to \<480 milliseconds, \>=480 to \<500 milliseconds, \>=500 milliseconds, increase from baseline \>=30 - \<60, increase from baseline \>=60, PR interval: \>=300 milliseconds, increase from baseline \>=25%; QRS duration: \>=140 milliseconds, increase from baseline \>=50%; QT interval: \>=500 milliseconds; QT Interval: \>= 500 milliseconds.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria QRS Duration: >=140 milliseconds	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria QRS Duration: Increase from baseline >=50%	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria QT Interval: >=500 milliseconds	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria QTCF: >=450 - <480 milliseconds	2 Participants	2 Participants	1 Participants	4 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria QTCF: >=480 - <500 milliseconds	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria QTCF: >=500 milliseconds	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria QTCF: Increase from baseline >=30 - <60 milliseconds	2 Participants	0 Participants	0 Participants	3 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria QTCF: Increase from baseline >=60 milliseconds	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria PR Interval: >=300 milliseconds	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria PR Interval: Increase from baseline >=25%	1 Participants	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Screening (2 to 28 days prior to Day 1), Day -1 (1 day prior to Day 1), safety follow up (Visit up to Day 52)

Population: Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.

As per ECOG, participant's performance status was measured as: 0=fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature, e.g., light housework, office work; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Day -1 · ECOG Performance Status: 1	5 Participants	9 Participants	2 Participants	11 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Day -1 · ECOG Performance Status: 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Screening · ECOG Performance Status: 0	3 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Screening · ECOG Performance Status: 1	4 Participants	8 Participants	2 Participants	12 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Screening · ECOG Performance Status: 2	0 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Screening · ECOG Performance Status: 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Screening · ECOG Performance Status: 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Day -1 · ECOG Performance Status: 0	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Day -1 · ECOG Performance Status: 2	0 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Day -1 · ECOG Performance Status: 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Safety follow up · ECOG Performance Status: 0	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Safety follow up · ECOG Performance Status: 1	2 Participants	4 Participants	0 Participants	1 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Safety follow up · ECOG Performance Status: 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Safety follow up · ECOG Performance Status: 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Safety follow up · ECOG Performance Status: 4	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 30 days after last dose of study drug (up to 52 days)

Population: Safety analysis set included all participants who received any amount of talazoparib.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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/incapacity; congenital anomaly; medically important events. TEAEs were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	6 Participants	8 Participants	3 Participants	14 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	1 Participants	3 Participants	2 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 30 days after last dose of study drug (up to 52 days)

Population: Safety analysis set included all participants who received any amount of talazoparib.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs leading to study drug discontinuation are reported.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Number of Participants With TEAEs Leading to Study Drug Discontinuation	0 Participants	2 Participants	2 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 30 days after last dose of study drug (up to 52 days)

Population: Safety analysis set included all participants who received any amount of talazoparib.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs resulting in death are reported.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Number of Participants With TEAEs Resulting in Death	0 Participants	0 Participants	1 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 30 days after last dose of study drug (up to 52 days)

Population: Safety analysis set included all participants who received any amount of talazoparib.

A treatment-related adverse event was any untoward medical occurrence attributed to talazoparib in a participant who received talazoparib. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; Congenital anomaly. Relatedness to talazoparib was assessed by the investigator.

Outcome measures

Outcome measures
Measure	Talazoparib: Normal Hepatic Function n=7 Participants Participants with TB and AST \<=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.	Talazoparib: Mild Hepatic Impairment n=10 Participants Participants with TB \<=ULN and AST greater than (\>) ULN or TB \>1.0 to 1.5\* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Moderate Hepatic Impairment n=5 Participants Participants with TB \>1.5 to 3.0 \*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.	Talazoparib: Severe Hepatic Impairment n=16 Participants Participants with TB \>3\*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.
Number of Participants With Treatment Emergent Treatment Related Adverse Events and SAEs SAEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Treatment Related Adverse Events and SAEs AEs	4 Participants	3 Participants	0 Participants	2 Participants

Adverse Events

Talazoparib: Normal Hepatic Function

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Talazoparib: Mild Hepatic Impairment

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Talazoparib: Moderate Hepatic Impairment

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Talazoparib: Severe Hepatic Impairment

Serious events: 13 serious events

Other events: 10 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER