A Study to Investigate the Effect of PH-797804 on QTc Interval

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval

Official Title
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A Phase 1, Randomized, Placebo-And Positive-Controlled Crossover Study To Determine The Effect Of A Single-Dose Of PH-797804 On QTc Interval In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: PH-797804
* Drug: Moxifloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. History of regular alcohol consumption exceeding 14 drinks/week for males.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PH-797804<br>Subjects will receive a single 24 mg dose in the fed state | Drug: PH-797804<br>* Tablet, 24 mg, single dose<br>|
| Experimental: Moxifloxacin<br>Subjects will receive a single 400 mg dose in the fed state | Drug: Moxifloxacin<br>* Tablet, 400 mg, single dose<br>|
| Experimental: Placebo<br>Subjects will receive a single placebo dose | Drug: Placebo<br>* Tablet, PH-797804 matched placebo, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTcF Interval | QT interval corrected for heart rate using Fredericias correction | -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTcI Interval | QT interval using individual heart rate correction | -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | 0,0.5,2,4,5,6,7,8,12,24 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0,0.5,2,4,5,6,7,8,12,24 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0,0.5,2,4,5,6,7,8,12,24 hours post-dose |