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Completed

NCT Number: NCT01173536

A 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.

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Key information

Conditions

Healthy Volunteer

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0449

Drug

Oral repeating dose

moxifloxacin

Drug

Oral single dose

Placebo

Drug

Oral repeating dose

Primary outcomes

  1. The QTcF (QT interval corrected by Fridericia's correction method)

    Time frame: Throughout study or until early discontinuation

Secondary outcomes

  1. Change in ECG from baseline

    Time frame: Throughout study or until early discontinuation

  2. Pharmacokinetic parameters of GDC-0449

    Time frame: Throughout study or until early discontinuation

  3. Incidence, nature and severity of adverse events

    Time frame: Throughout study or until early discontinuation

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2010
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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