An Open-Label, 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
Overview
- Phase
- Phase 1
- Intervention
- rabeprazole
- Conditions
- Healthy Volunteer
- Sponsor
- Genentech, Inc.
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Maximum plasma concentration
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 3: Group A
Intervention: rabeprazole
Part 1
Intervention: GDC-0980
Part 2
Intervention: GDC-0980
Part 3: Group A
Intervention: GDC-0980
Part 3: Group B
Intervention: GDC-0980
Part 3: Group B
Intervention: rabeprazole
Outcomes
Primary Outcomes
Maximum plasma concentration
Time Frame: Up to day 10
Time to maximum observed plasma concentration
Time Frame: Up to day 10
Plasma half-life
Time Frame: Up to day 10
Oral clearance
Time Frame: Up to day 10
Volume of distribution
Time Frame: Up to day 10
Minimum plasma concentration
Time Frame: Up to day 10
Secondary Outcomes
- Incidence of adverse events(Up to day 68)
- Nature of adverse events(Up to day 68)
- Severity of adverse events(Up to day 68)