NCT01967966

A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers

A PHASE 1 STUDY TO INVESTIGATE THE ABSOLUTE BIOAVAILABILITY OF GDC-0032 AND THE ABSORPTION, METABOLISM, AND EXCRETION OF [14C]-GDC-0032 IN HEALTHY MALE SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GDC-0032	Single oral dose
DRUG	GDC-0032	Single IV dose

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-10-23
• Last updated: 2016-11-02

Locations

1 site across 1 country: United States