NCT01240226
Completed
Phase 1
An Open-Label, 2-Part Study to Determine the Relative Bioavailability of a Tablet Formulation of GDC-0941 and the Effect of Ketoconazole on the Pharmacokinetics of the GDC-0941 Tablet
Overview
- Phase
- Phase 1
- Intervention
- GDC-0941
- Conditions
- Healthy Volunteer
- Sponsor
- Genentech, Inc.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This will be a single-center, open-label, randomized, 2-part study to determine the relative bioavailability of GDC-0941 capsule and market-image tablet formulations and the effect of ketoconazole on the pharmacokinetics of the GDC-0941 market-image tablet formulation.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Intervention: GDC-0941
A
Intervention: ketoconazole
B
Intervention: GDC-0941
B
Intervention: ketoconazole
Outcomes
Primary Outcomes
Pharmacokinetic parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)
Time Frame: Prior to and after GDC-0941 dosing
Incidence, nature, and severity of adverse events
Time Frame: Through study completion or early study discontinuation
Study Sites (1)
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