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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT01173536
First received: July 29, 2010
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

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: Double Blind (Subject, 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:

Primary Outcome Measures:
  • The QTcF (QT interval corrected by Fridericia's correction method) [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in ECG from baseline [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0449 [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature and severity of adverse events [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: August 2010
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173536

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

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01173536     History of Changes
Other Study ID Numbers: SHH4871g
Study First Received: July 29, 2010
Last Updated: August 17, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014