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

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173536
• Other study ID #: SHH4871g
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2010
• Last updated: February 16, 2017
• Start date: August 25, 2010
• Est. completion date: March 18, 2011

Study information

• Verified date: February 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 18, 2011
• Est. primary completion date: March 18, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0449
Oral repeating dose
• moxifloxacin
Oral single dose
• placebo
Oral repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The QTcF (QT interval corrected by Fridericia's correction method)		Throughout study or until early discontinuation
Secondary	Change in ECG from baseline		Throughout study or until early discontinuation
Secondary	Pharmacokinetic parameters of GDC-0449		Throughout study or until early discontinuation
Secondary	Incidence, nature and severity of adverse events		Throughout study or until early discontinuation