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

• Status: Completed
• Trial end date: 2011-03-18
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Moxifloxacin

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