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

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: moxifloxacin

Drug: placebo

Drug: GDC-0449

Study type

Interventional

Funder types

Industry

Identifiers

NCT01173536

SHH4871g

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

Female

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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