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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GDC-0449 oral capsules (non-labeled); Drug: CDC-0449 oral suspension (labeled); Drug: GDC-0449 IV injection (labeled)

• Registration Number: NCT00991718
• Lead Sponsor: Genentech, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
A	GDC-0449 oral capsules (non-labeled)	On Day 1, subjects received a single oral dose of non-labeled GDC-0449 and a single IV tracer dose of 14C-GDC-0449.
A	GDC-0449 IV injection (labeled)	On Day 1, subjects received a single oral dose of non-labeled GDC-0449 and a single IV tracer dose of 14C-GDC-0449.
B	CDC-0449 oral suspension (labeled)	On Day 1, subjects received a single oral dose of 14C-GDC-0449.
C	GDC-0449 oral capsules (non-labeled)	On Days 1-7, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects also received a single IV tracer dose of 14C-GDC-0449.
C	GDC-0449 IV injection (labeled)	On Days 1-7, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects also received a single IV tracer dose of 14C-GDC-0449.
D	GDC-0449 oral capsules (non-labeled)	On Days 1-6, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects received a single oral dose of 14C-GDC-0449.
D	CDC-0449 oral suspension (labeled)	On Days 1-6, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects received a single oral dose of 14C-GDC-0449.

Primary Outcome Measures

Name	Time	Method
PK (Max observed and time to max plasma concentrations, area under the plasma concentration-time curve, absolute bioavailability, total plasma clearance, vol of dist, plasma terminal phase half-life, cumulative % excretion in urine and feces [Part B])	Until study discontinuation

Secondary Outcome Measures

Name	Time	Method
Safety outcome measures (incidence, nature, and severity of adverse events; change in clinical laboratory results; change in vital signs; change in electrocardiogram [ECG]; and change in physical examination findings)	Until study discontinuation