A Phase 1, Open-Label, Single-Dose, Two-Period, Fixed Sequence, Crossover Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Divarasib
- Conditions
- Healthy Participants
- Sponsor
- Genentech, Inc.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Maximum Plasma Concentration (Cmax) of Divarasib
- Status
- Completed
- Last Updated
- last year
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 Itraconazole on the pharmacokinetics (PK) and safety of Divarasib in healthy participants.
Investigators
Eligibility Criteria
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
Treatment B
Participants will receive Itraconazole twice a day (BID) on Day 1 and once a day (QD) from Day 2 to Day 13. Participants will receive Divarasib in combination with Itraconazole on Day 5.
Intervention: Divarasib
Treatment B
Participants will receive Itraconazole twice a day (BID) on Day 1 and once a day (QD) from Day 2 to Day 13. Participants will receive Divarasib in combination with Itraconazole on Day 5.
Intervention: Itraconazole
Outcomes
Primary Outcomes
Maximum Plasma Concentration (Cmax) of Divarasib
Time Frame: Day 1 of Period 1 and Day 5 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 5 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 5 of Period 2
Secondary Outcomes
- Percentage of Participants With Adverse Events (AEs)(Up to Week 12)