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Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Pamiparib in Participants With Advanced Cancer

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Pamiparib Following Single Oral Dose Administration in Patients With Advanced and/or Metastatic Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03991494
Enrollment
4
Registered
2019-06-19
Start date
2019-05-29
Completion date
2020-08-05
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Brief summary

This is an open-label study, in participants with advanced and/or metastatic solid tumors, which consists of 2 parts: a research phase (inpatient) and a treatment phase. The research phase (Part 1) of the study will assess the disposition of a single oral dose of \[14C\]-pamiparib. In the treatment phase (Part 2) participants will be allowed to have continued access to pamiparib.

Interventions

DRUG[14C]-pamiparib

During the treatment phase, pamiparib 60 mg administered orally twice daily

Sponsors

BeiGene
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Key Inclusion Criteria: 1. Histologically and/or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with approved therapies for which there are no standard therapies available 2. A total body weight between 50 and 100 kg, inclusive at Screening 3. Measurable disease by CT/MRI 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 5. Adequate organ function Key

Exclusion criteria

1. Clinically significant cardiovascular disease 2. Have a previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome. 3. Poor peripheral venous access 4. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 2 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study 5. Use or have anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers NOTE: Other protocol defined Inclusion/

Design outcomes

Primary

MeasureTime frame
Cumulative Recovery of Total Radioactivity in Total Excreta192 hours of [14C]-Pamiparib Administration
Percentage of Total Radioactivity Excreted in Urine192 hours of [14C]-Pamiparib Administration
Cumulative Urinary Excretion of Pamiparib192 hours of [14C]-Pamiparib Administration
Renal Clearance of Pamiparib (CLR)192 hours of [14C]-Pamiparib Administration
Fecal Recovery of Total Radioactivity192 hours of [14C]-Pamiparib Administration
Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of PamiparibPre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F)Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total RadioactivityPre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total RadioactivityPre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Secondary

MeasureTime frameDescription
Number of Participants With Clinically Significant Laboratory AbnormalitiesUp to 6 months—
Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight DataUp to 6 months—
Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3)0.5, 1, 2, 6, 12, 24, 48, 72, 96, 120, and 144 hours post dose on Days 1 to 7Human plasma, urine, and feces samples were analyzed by LC-MS.
Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2Up to 6 months—

Countries

United Kingdom

Participant flow

Recruitment details

The study consisted of 2 parts: a Research Phase (Part 1) in which participants were inpatients and a Treatment Phase (Part 2) in which participants were outpatients.

Pre-assignment details

Potential participants were screened to assess their eligibility to enter the study within 28 days prior to administration of the first dose. Up to 10 participants could be enrolled to ensure that 4 participants completed Part 1 of the study.

Participants by arm

ArmCount
Pamiparib
Research Phase (Part 1): participants received a single dose of 60 mg \[14C\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally
4
Total4

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyProgressive Disease4

Baseline characteristics

CharacteristicPamiparib
Age, Continuous56 years
STANDARD_DEVIATION 5.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
4 Participants
Region of Enrollment
United Kingdom
4 participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 4
other
Total, other adverse events
4 / 4
serious
Total, serious adverse events
0 / 4

Outcome results

Primary

Cumulative Recovery of Total Radioactivity in Total Excreta

Time frame: 192 hours of [14C]-Pamiparib Administration

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (MEAN)Dispersion
PamiparibCumulative Recovery of Total Radioactivity in Total Excreta84.73 % ExcretedStandard Deviation 3.53
Primary

Cumulative Urinary Excretion of Pamiparib

Time frame: 192 hours of [14C]-Pamiparib Administration

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibCumulative Urinary Excretion of Pamiparib1.095 mgGeometric Coefficient of Variation 40.2
Primary

Fecal Recovery of Total Radioactivity

Time frame: 192 hours of [14C]-Pamiparib Administration

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (MEAN)Dispersion
PamiparibFecal Recovery of Total Radioactivity26.89 % ExcretedStandard Deviation 6.83
Primary

Percentage of Total Radioactivity Excreted in Urine

Time frame: 192 hours of [14C]-Pamiparib Administration

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (MEAN)Dispersion
PamiparibPercentage of Total Radioactivity Excreted in Urine57.84 % ExcretedStandard Deviation 5.12
Primary

Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (MEAN)Dispersion
PamiparibPlasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)29.2 hoursStandard Deviation 6.02
Primary

Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F)2.21 Liters/hour (L/h)Geometric Coefficient of Variation 23.2
Primary

Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F)91.3 LitersGeometric Coefficient of Variation 18.5
Primary

Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞)29300 hours*nanograms/milliLiter (h*ng/mL)Geometric Coefficient of Variation 21.6
Primary

Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity0.694 RatioGeometric Coefficient of Variation 2.7
Primary

Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t)29200 h*ng/mLGeometric Coefficient of Variation 21.6
Primary

Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib2190 ng/mLGeometric Coefficient of Variation 12.4
Primary

Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (MEDIAN)
PamiparibPlasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax)2.00 hours
Primary

Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity0.764 RatioGeometric Coefficient of Variation 5.8
Primary

Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureGroupValue (MEAN)Dispersion
PamiparibPlasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)Plasma Total Radioactivity21.6 hoursStandard Deviation 10.3
PamiparibPlasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)Whole Blood Total Radioactivity13.3 hoursStandard Deviation 3.13
Primary

Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)Plasma Total Radioactivity42200 h*ngEq/gGeometric Coefficient of Variation 21.5
PamiparibPlasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)Whole Blood Total Radioactivity32200 h*ngEq/gGeometric Coefficient of Variation 16.2
Primary

Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)Plasma Total Radioactivity41800 h*ngEq/gGeometric Coefficient of Variation 21.6
PamiparibPlasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)Whole Blood Total Radioactivity31200 h*ngEq/gGeometric Coefficient of Variation 16.1
Primary

Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PamiparibPlasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax)Plasma Total Radioactivity2390 ngEq/gGeometric Coefficient of Variation 9
PamiparibPlasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax)Whole Blood Total Radioactivity1730 ngEq/gGeometric Coefficient of Variation 11.8
Primary

Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7

Population: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureGroupValue (MEDIAN)
PamiparibPlasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax)Plasma Total Radioactivity2.25 hours
PamiparibPlasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax)Whole Blood Total Radioactivity2.25 hours
Primary

Renal Clearance of Pamiparib (CLR)

Time frame: 192 hours of [14C]-Pamiparib Administration

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PamiparibRenal Clearance of Pamiparib (CLR)0.03742 CLR (L/h)Geometric Coefficient of Variation 59.5
Secondary

Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data

Time frame: Up to 6 months

Population: The safety population for Part 1 consisted of all participants who received at least 1 dose of study drug, 60 mg \[14C\]-pamiparib, in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2.

ArmMeasureValue (NUMBER)
PamiparibNumber of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data0 Number of participants
Secondary

Number of Participants With Clinically Significant Laboratory Abnormalities

Time frame: Up to 6 months

Population: The safety population for Part 1 consisted of all participants who received 1 dose of study drug, 60 mg \[14C\]-pamiparib, in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2.

ArmMeasureValue (NUMBER)
PamiparibNumber of Participants With Clinically Significant Laboratory Abnormalities0 number of participants
Secondary

Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2

Time frame: Up to 6 months

Population: The safety population for Part 1 consisted of all participants who received 1 dose of study drug, 60 mg \[14C\]-pamiparib in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2.

ArmMeasureGroupValue (NUMBER)
PamiparibNumber of Participants With Treatment Emergent Adverse Events in Part1 and Part 2Part 1: Number of Participants with AEs4 number of participants
PamiparibNumber of Participants With Treatment Emergent Adverse Events in Part1 and Part 2Part 1: Participants with SAEs0 number of participants
PamiparibNumber of Participants With Treatment Emergent Adverse Events in Part1 and Part 2Part 2: Number of Participants with AEs3 number of participants
PamiparibNumber of Participants With Treatment Emergent Adverse Events in Part1 and Part 2Part 2: Participants with SAEs0 number of participants
Secondary

Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3)

Human plasma, urine, and feces samples were analyzed by LC-MS.

Time frame: 0.5, 1, 2, 6, 12, 24, 48, 72, 96, 120, and 144 hours post dose on Days 1 to 7

Population: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

ArmMeasureValue (NUMBER)
PamiparibPamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3)313.1098 Da

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026