A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers

Study Overview
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Brief Summary
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A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.

Official Title
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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

Conditions
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Pulmonary Disease, Lung Disease, Moxifloxacin

Intervention / Treatment
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* Drug: PF-00610355
* Drug: PF-00610355
* Drug: moxifloxacin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-00610355 450 µg<br>An orally inhaled dose of PF-00610355 450 µg | Drug: PF-00610355<br>* An orally inhaled dose of PF-00610355 450 µg on days 1 to 4<br>|
| Experimental: PF-00610355 1200 µg<br>An orally inhaled dose of PF-00610355 1200 µg | Drug: PF-00610355<br>* An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4<br>|
| Active Comparator: moxifloxacin 400 mg<br>A single oral dose of moxifloxacin 400 mg on Day 4. | Drug: moxifloxacin<br>* A single oral dose of moxifloxacin 400 mg on Day 4.<br>|
| Placebo Comparator: placebo<br>A single oral dose of non-matched placebo on Day 4. | Drug: placebo<br>* A single oral dose of non-matched placebo on Day 4.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers |  | 24 hours | 
| To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QTC