A 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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: GDC-0941; Drug: ketoconazole

• Registration Number: NCT01240226
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-15
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-07
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	GDC-0941	-
B	GDC-0941	-
A	ketoconazole	-
B	ketoconazole	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)	Prior to and after GDC-0941 dosing
Incidence, nature, and severity of adverse events	Through study completion or early study discontinuation

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Austin, Texas, United States