A 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
- Registration Number
- NCT01287091
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 3: Group B rabeprazole - Part 3: Group A GDC-0980 - Part 1 GDC-0980 - Part 3: Group B GDC-0980 - Part 2 GDC-0980 - Part 3: Group A rabeprazole -
- Primary Outcome Measures
Name Time Method Maximum plasma concentration Up to day 10 Time to maximum observed plasma concentration Up to day 10 Plasma half-life Up to day 10 Oral clearance Up to day 10 Volume of distribution Up to day 10 Minimum plasma concentration Up to day 10
- Secondary Outcome Measures
Name Time Method Nature of adverse events Up to day 68 Severity of adverse events Up to day 68 Incidence of adverse events Up to day 68
Trial Locations
- Locations (1)
Investigational Site
🇺🇸Austin, Texas, United States