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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: July 29, 2010
Last updated: February 16, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Healthy Volunteer
Drug: GDC-0449
Drug: moxifloxacin
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • The QTcF (QT interval corrected by Fridericia's correction method) [ Time Frame: Throughout study or until early discontinuation ]

Secondary Outcome Measures:
  • Change in ECG from baseline [ Time Frame: Throughout study or until early discontinuation ]
  • Pharmacokinetic parameters of GDC-0449 [ Time Frame: Throughout study or until early discontinuation ]
  • Incidence, nature and severity of adverse events [ Time Frame: Throughout study or until early discontinuation ]

Enrollment: 61
Actual Study Start Date: August 25, 2010
Study Completion Date: March 18, 2011
Primary Completion Date: March 18, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: moxifloxacin
Oral single dose
Drug: placebo
Oral repeating dose
Active Comparator: B Drug: moxifloxacin
Oral single dose
Drug: placebo
Oral repeating dose
Experimental: C Drug: GDC-0449
Oral repeating dose
Drug: placebo
Oral repeating dose


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01173536

Sponsors and Collaborators
Genentech, Inc.
Study Director: Jean Ayache, M.D. Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01173536     History of Changes
Other Study ID Numbers: SHH4871g
Study First Received: July 29, 2010
Last Updated: February 16, 2017

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on April 28, 2017