Status:
COMPLETED
A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
FEMALE
45+ years
Phase:
PHASE1
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01173536
Start Date
August 25 2010
End Date
March 18 2011
Last Update
February 17 2017
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