A 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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: GDC-0941; Drug: rabeprazole

• Registration Number: NCT00999128
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Study Start: 2009-10-26
• Status Verified: 2010-02
• Primary Completion: 2010-02-26
• Study Completion: 2010-02-26
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1	GDC-0941	-
Part 2	GDC-0941	-
Part 2	rabeprazole	-

Primary Outcome Measures

Name	Time	Method
Incidence, nature, and severity of adverse events	Through study completion or early study discontinuation
PK parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)	Following administration of study drug

Trial Locations

Locations (1)

Genentech Trial Information Support; 🇺🇸 South San Francisco, California, United States