A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
NCT ID: NCT01107054
Last Updated: 2011-01-13
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
48 participants
INTERVENTIONAL
2010-06-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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PF-00610355 450 µg
An orally inhaled dose of PF-00610355 450 µg
PF-00610355
An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
PF-00610355 1200 µg
An orally inhaled dose of PF-00610355 1200 µg
PF-00610355
An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
moxifloxacin 400 mg
A single oral dose of moxifloxacin 400 mg on Day 4.
moxifloxacin
A single oral dose of moxifloxacin 400 mg on Day 4.
placebo
A single oral dose of non-matched placebo on Day 4.
placebo
A single oral dose of non-matched placebo on Day 4.
Interventions
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PF-00610355
An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
PF-00610355
An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
moxifloxacin
A single oral dose of moxifloxacin 400 mg on Day 4.
placebo
A single oral dose of non-matched placebo on Day 4.
Eligibility Criteria
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Inclusion Criteria
* Informed consent document signed by the subject or a legally acceptable representative
* Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures
Exclusion Criteria
* Conditions possibly affecting drug absorption
* 12-lead ECg demonstrating QTc \> 450ms or any other clinically significant abnormalities at screen
* Positive urine drug screen
* Hypersensitivity to moxifloxacin or PF00610335
* Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Brussels, , Belgium
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A7881014
Identifier Type: -
Identifier Source: org_study_id
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