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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01173536
Collaborator
(none)
61
Enrollment
3
Arms
6.7
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (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
Actual Study Start Date :
Aug 25, 2010
Actual Primary Completion Date :
Mar 18, 2011
Actual Study Completion Date :
Mar 18, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. The QTcF (QT interval corrected by Fridericia's correction method) [Throughout study or until early discontinuation]

Secondary Outcome Measures

  1. Change in ECG from baseline [Throughout study or until early discontinuation]

  2. Pharmacokinetic parameters of GDC-0449 [Throughout study or until early discontinuation]

  3. Incidence, nature and severity of adverse events [Throughout study or until early discontinuation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
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

Locations

No locations specified.

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Jean Ayache, M.D., Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01173536
Other Study ID Numbers:
  • SHH4871g
First Posted:
Aug 2, 2010
Last Update Posted:
Feb 17, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Moxifloxacin

Study Results

No Results Posted as of Feb 17, 2017