NCT00991718

A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential

A Phase I, Open-Label Absorption, Distribution, Metabolism, and Excretion (ADME) Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part A and dosing the first subject in Part B. In each part, 6 healthy female subjects of non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GDC-0449 oral capsules (non-labeled)	150 mg oral capsule
DRUG	GDC-0449 IV injection (labeled)	10 mcg (in 2 mL) IV dose of 14C-GDC-0449
DRUG	CDC-0449 oral suspension (labeled)	30-mL oral suspension containing 6.5 mcg 14CGDC-0449 and 150 mg GDC-0449

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-10-08
• Last updated: 2017-06-26