NCT01240226

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GDC-0941	Oral repeating dose
DRUG	GDC-0941	Oral repeating dose
DRUG	ketoconazole	Oral repeating dose

Timeline

• Start date: 2010-11-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-11-15
• Last updated: 2017-03-03

Locations

1 site across 1 country: United States