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

NCT01173536 | Completed Phase 1

• 1 other identifier: SHH4871g
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• The QTcF (QT interval corrected by Fridericia's correction method)

  Throughout study or until early discontinuation

Secondary Outcomes (3)

• 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

Study Arms (3)

A

ACTIVE COMPARATOR

Drug: moxifloxacin; Drug: placebo

B

ACTIVE COMPARATOR

Drug: moxifloxacin; Drug: placebo

C

EXPERIMENTAL

Drug: GDC-0449; Drug: placebo

Interventions

GDC-0449 DRUG

Oral repeating dose

C

moxifloxacin DRUG

Oral single dose

A; B

placebo DRUG

Oral repeating dose

A; B; C

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Interventions

HhAntag691; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean Ayache, M.D.

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: August 25, 2010
• Primary Completion: March 18, 2011
• Study Completion: March 18, 2011
• Last Updated: February 17, 2017

Record last verified: 2017-02