A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function
- 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does Divarasib's pharmacokinetics vary across Child-Pugh A/B/C hepatic impairment classifications?
What molecular pathways does Divarasib target in hepatic function modulation?
Are there predictive biomarkers for Divarasib efficacy in patients with hepatic impairment?
What adverse event profiles are observed for Divarasib in phase 1 hepatic impairment trials?
How does Divarasib compare to other investigational agents in hepatic impairment drug development?
Trial Locations
- Locations (1)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Orlando Clinical Research Center🇺🇸Orlando, Florida, United States