A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects
NCT ID: NCT01173536
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2010-08-25
2011-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
moxifloxacin
Oral single dose
placebo
Oral repeating dose
B
moxifloxacin
Oral single dose
placebo
Oral repeating dose
C
GDC-0449
Oral repeating dose
placebo
Oral repeating dose
Interventions
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GDC-0449
Oral repeating dose
moxifloxacin
Oral single dose
placebo
Oral repeating dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
FEMALE
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Ayache, M.D.
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Other Identifiers
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SHH4871g
Identifier Type: -
Identifier Source: org_study_id
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