- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01107054
A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
January 12, 2011 updated by: Pfizer
A Double Blind, Randomized, Multiple Dose, Placebo And Active Controlled 4-Way Crossover Study To Investigate The Effects Of Inhaled PF-00610355 On QT/QTC Interval In Healthy Subjects
A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bruxelles, Belgium, 1070
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and female subjects aged 18 to 55 years
- 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:
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PF-00610355 450 µg
An orally inhaled dose of PF-00610355 450 µg
|
An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
|
Experimental: PF-00610355 1200 µg
An orally inhaled dose of PF-00610355 1200 µg
|
An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
|
Active Comparator: moxifloxacin 400 mg
A single oral dose of moxifloxacin 400 mg on Day 4.
|
A single oral dose of moxifloxacin 400 mg on Day 4.
|
Placebo Comparator: placebo
A single oral dose of non-matched placebo on Day 4.
|
A single oral dose of non-matched placebo on Day 4.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers
Time Frame: 24 hours
|
24 hours
|
To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
April 19, 2010
First Submitted That Met QC Criteria
April 19, 2010
First Posted (Estimate)
April 20, 2010
Study Record Updates
Last Update Posted (Estimate)
January 13, 2011
Last Update Submitted That Met QC Criteria
January 12, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A7881014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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