A Phase 1, Open-Label, Single-Dose, Parallel-Cohort Study to Evaluate the Pharmacokinetics of Divarasib in Subjects With Impaired Hepatic Function
Overview
- Phase
- Phase 1
- Intervention
- Divarasib
- Conditions
- Hepatic Impairment
- Sponsor
- Genentech, Inc.
- Enrollment
- 31
- Locations
- 4
- Primary Endpoint
- Plasma Concentration of Divarasib
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh classification.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
Participants will receive a single oral dose of Divarasib on Day 1.
Intervention: Divarasib
Cohort 2
Participants will receive a single oral dose of Divarasib on Day 1.
Intervention: Divarasib
Cohort 3
Participants will receive a single oral dose of Divarasib on Day 1.
Intervention: Divarasib
Cohort 4
Participants will receive a single oral dose of Divarasib on Day 1.
Intervention: Divarasib
Outcomes
Primary Outcomes
Plasma Concentration of Divarasib
Time Frame: Day 1 to Day 7
Maximum Observed Concentration (Cmax) of Divarasib
Time Frame: Day 1 to Day 7
Area Under the Concentration-time Curve from Hour 0 to the last measurable concentration (AUC0-t) of Divarasib
Time Frame: Day 1 to Day 7
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib
Time Frame: Day 1 to Day 7
Secondary Outcomes
- Percentage of Participants With Adverse Events (AEs)(Up to Week 10)