A Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Divarasib in Healthy Participants
- Registration Number
- NCT06835465
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is a phase 1, open-label, two-period, fixed sequence drug-drug interaction study to evaluate the impact of multiple doses of rifampin on the pharmacokinetics (PK) and safety of divarasib in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Males or females of non-childbearing potential
- Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive
Exclusion Criteria
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- Poor peripheral venous access
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A Divarasib Participants will receive a single oral dose of Divarasib on Day 1. Treatment B Divarasib Participants will receive Rifampin once daily (QD) on Days 1 to 7 and Days 9 to 13. Participants will receive Divarasib followed by Rifampin on Day 8. Treatment B Rifampin Participants will receive Rifampin once daily (QD) on Days 1 to 7 and Days 9 to 13. Participants will receive Divarasib followed by Rifampin on Day 8.
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of Divarasib Day 1 of Period 1 and Day 8 of Period 2 Area Under the Concentration-time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Divarasib Day 1 of Period 1 and Day 8 of Period 2 Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib Day 1 of Period 1 and Day 8 of Period 2
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Up to Week 14
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 rifampin-induced CYP3A4 activity alter divarasib's plasma concentration and KIT receptor inhibition in healthy volunteers?
What are the comparative PK profiles of divarasib with rifampin versus other CYP inducers in Phase 1 drug interaction studies?
Which genetic biomarkers (e.g., CYP2C8 polymorphisms) correlate with divarasib-rifampin interaction outcomes in Genentech trials?
What are the most common adverse events reported in divarasib-rifampin co-administration studies and their management protocols?
How do divarasib's PK interactions with rifampin compare to those of imatinib or sunitinib in CYP-mediated drug-drug interaction research?
Trial Locations
- Locations (1)
Fortrea Dallas CRU
🇺🇸Dallas, Texas, United States