Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.

Official Title
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A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 On Qt Intervals In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-00232798
* Drug: PF-00232798
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. 12-lead ECG demonstrating QTc >450 msec at screening. Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. History of orthostatic symptoms or orthostatic hypotension at screening. Pregnant or nursing females; females of childbearing potential.

Ages Eligible for Study
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Minimum Age: 21 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-00232798 supratherapeutic dose<br>PF-00232798 supratherapeutic dose | Drug: PF-00232798<br>* 600 mg oral solution once daily x 7 days<br>|
| Experimental: PF-00232798 therapeutic dose<br>PF-00232798 therapeutic dose | Drug: PF-00232798<br>* 300 mg oral solution once daily x 7 days<br>|
| Placebo Comparator: Placebo for PF-00232798<br>Placebo for PF-00232798 | Drug: Placebo<br>* Oral solution once daily x 7 days<br>|
| Active Comparator: Moxifloxacin<br>Moxifloxacin | Drug: Moxifloxacin<br>* 400 mg tablet single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7 |  | 7 days | 
| QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7 |  | 7 days | 
| Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast) |  | 7 days | 
| Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QT, PF-00232798, CCR5, QTc, pharmacokinetics