An Open-Label, Two-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- GDC-0941
- Conditions
- Healthy Volunteers
- Sponsor
- Genentech, Inc.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence, nature, and severity of adverse events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of the tablet formulation of GDC-0941 (Part 2). Approximately 18 subjects will be enrolled in Part 1 and up to 32 subjects will be enrolled in Part 2. Subjects who participate in Part 1 are not eligible to participate in Part 2.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 1
Intervention: GDC-0941
Part 2
Intervention: GDC-0941
Part 2
Intervention: rabeprazole
Outcomes
Primary Outcomes
Incidence, nature, and severity of adverse events
Time Frame: Through study completion or early study discontinuation
PK parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)
Time Frame: Following administration of study drug