NCT01287091

A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet

An Open-Label, 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GDC-0980	Oral tablet dose
DRUG	GDC-0980	Oral capsule dose
DRUG	GDC-0980	Oral tablet dose in fed state
DRUG	GDC-0980	Oral repeating dose in fasting state
DRUG	GDC-0980	Oral repeating dose in fed state
DRUG	GDC-0980	Oral tablet in a fasting state
DRUG	rabeprazole	Oral repeating dose

Timeline

• Start date: 2010-10-14
• Primary completion: 2011-02-03
• Completion: 2011-02-03
• First posted: 2011-02-01
• Last updated: 2022-12-13

Locations

1 site across 1 country: United States