drugset / Trial / NCT00999128

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

NCT00999128

Phase 1 Completed 50 enrolled Genentech, Inc.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2009-10-26
Primary completion
2010-02-26
Completion
2010-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Pictilisib Small molecule Oral
Subject Rabeprazole Small molecule Oral

Indications

No indication recorded.