A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: moxifloxacin; Drug: GDC-0449; Drug: placebo

• Registration Number: NCT01173536
• Lead Sponsor: Genentech, Inc.

Brief Summary

This is a Phase I, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-08-02
• Study Start: 2010-08-25
• Primary Completion: 2011-03-18
• Study Completion: 2011-03-18
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• Female, over 45 years of age
• In good health, as determined by the absence of clinically significant findings from the screening visit
• Body mass index between 18 and 32 kg/m^2 inclusive, with a body weight > 45 kg
• Of non-childbearing potential

Exclusion Criteria

• History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiac, vascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer; or cirrhosis
• Allergy to moxifloxacin or any quinolone antibiotics or any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
• Personal or family history of congenital long QT syndrome or family history of sudden death
• Participation in an investigational drug or device study with an investigational drug within the last 3 months or six times the elimination half-life, whichever is longer, prior to Day 1 of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	placebo	-
B	moxifloxacin	-
B	placebo	-
C	GDC-0449	-
C	placebo	-
A	moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
The QTcF (QT interval corrected by Fridericia's correction method)	Throughout study or until early discontinuation

Secondary Outcome Measures

Name	Time	Method
Incidence, nature and severity of adverse events	Throughout study or until early discontinuation
Pharmacokinetic parameters of GDC-0449	Throughout study or until early discontinuation
Change in ECG from baseline	Throughout study or until early discontinuation