A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of co-administration with erythromycin on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.

Official Title
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A Phase 1, Randomised, Open Label, Two Sequence, Two Treatment, Two Way Crossover Study to Estimate the Steady-state Effect of Erythromycin on the Single Dose Pharmacokinetics of Ph-797804 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PH-797804
* Drug: PH-797804 + erythromycin


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 21 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 21 drinks/week for males.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PH-797804 6 mg<br>Subjects will receive a single 6 mg dose in the fed state | Drug: PH-797804<br>* Tablet, 6mg, single<br>|
| Experimental: PH-797804 6 mg + erythromycin 800 mg<br>Subjects will receive multiple 800 mg doses of erythromycin and a single 6 mg dose of PH-797804 in the fed state | Drug: PH-797804 + erythromycin<br>* PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose | 
| Plasma Decay Half-Life (t1/2) |  | 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |  | 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose |