A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT03807739
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is a two-part study to determine the relative bioavailability of two different prototype capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and fasted conditions. The study is open to healthy female participants of non-childbearing potential.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 38
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part I: GDC-0134 F16 vs F09 Capsule Formulation GDC-0134 F16 Formulation In Part 1 participants will receive single doses of either GDC-0134 F16 capsules (prototype) or GDC-0134 F09 capsules (reference) after having consumed a standard meal. Part II: GDC-0134 F15 vs F09 Capsule Formulation GDC-0134 F09 Formulation In Part 2, participants will receive a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast. Part I: GDC-0134 F16 vs F09 Capsule Formulation GDC-0134 F09 Formulation In Part 1 participants will receive single doses of either GDC-0134 F16 capsules (prototype) or GDC-0134 F09 capsules (reference) after having consumed a standard meal. Part II: GDC-0134 F15 vs F09 Capsule Formulation GDC-0134 F15 Formulation In Part 2, participants will receive a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.
- Primary Outcome Measures
Name Time Method Maximum Observed Concentration (Cmax) of GDC-0134. The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose. Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134 The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) From baseline through the end of study (approximately 11 weeks)
Trial Locations
- Locations (2)
Covance Research Unit - Dallas
🇺🇸Dallas, Texas, United States
Covance Research Unit - Daytona
🇺🇸Daytona Beach, Florida, United States