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

A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Active-Comparator, Parallel-Group Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: placebo; Drug: moxifloxacin; Drug: GDC-0449

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	Drug: placebo; Oral repeating dose; Drug: moxifloxacin; Oral single dose
Active Comparator: B	Drug: placebo; Oral repeating dose; Drug: moxifloxacin; Oral single dose
Experimental: C	Drug: placebo; Oral repeating dose; Drug: GDC-0449; Oral repeating dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Jean Ayache, M.D., Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2010
• Primary Completion (Actual): March 18, 2011
• Study Completion (Actual): March 18, 2011

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: July 29, 2010
• First Posted (Estimate): August 2, 2010

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: SHH4871g