A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function

Phase 1

Recruiting

• Conditions: Hepatic Impairment
• Interventions: Drug: Divarasib

• Registration Number: NCT06734208
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Study Start: 2025-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-10-20
• Study Completion: 2027-01-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Divarasib	Participants will receive a single oral dose of Divarasib on Day 1.
Cohort 2	Divarasib	Participants will receive a single oral dose of Divarasib on Day 1.
Cohort 3	Divarasib	Participants will receive a single oral dose of Divarasib on Day 1.
Cohort 4	Divarasib	Participants will receive a single oral dose of Divarasib on Day 1.

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of Divarasib	Day 1 to Day 7
Maximum Observed Concentration (Cmax) of Divarasib	Day 1 to Day 7
Area Under the Concentration-time Curve from Hour 0 to the last measurable concentration (AUC0-t) of Divarasib	Day 1 to Day 7
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib	Day 1 to Day 7

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Up to Week 10

Trial Locations

Locations (1)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States