A Phase 1, Open-Label, Single-Dose, Two-Period, Fixed Sequence, Crossover Study to Determine the Effect of Rifampin on the Pharmacokinetics of Divarasib in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Maximum Plasma Concentration (Cmax) of Divarasib
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Treatment A
Participants will receive a single oral dose of Divarasib on Day 1.
Intervention: Divarasib (Drug)
Treatment B
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.
Intervention: Divarasib (Drug)
Treatment B
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.
Intervention: Rifampin (Drug)
Outcomes
Primary Outcomes
Maximum Plasma Concentration (Cmax) of Divarasib
Time Frame: 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
Time Frame: Day 1 of Period 1 and Day 8 of Period 2
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib
Time Frame: Day 1 of Period 1 and Day 8 of Period 2
Secondary Outcomes
- Percentage of Participants With Adverse Events (AEs)(Up to Week 14)