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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01173536

Enrollment

Registered

2010-08-02

Start date

2010-08-25

Completion date

2011-03-18

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGGDC-0449

Oral repeating dose

DRUGmoxifloxacin

Oral single dose

DRUGplacebo

Oral repeating dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026