Food Effect Study PF-04136309

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of food intake on PF-04136309 pharmacokinetics (PK) following a single dose at 1000 mg.

Detailed Description
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The present study will be conducted in healthy adult subjects. The single dose of 1000 mg has been shown to be safe in a previous study in healthy subjects. To evaluate the effect of food on PF-04136309 PK at the dose of 1000 mg, which is the maximum dose that may be evaluated in the multiple dose setting in patients, will provide information to guide the dose administration in regards to food intake at relevant therapeutic dose levels for further studies in patients.

Official Title
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A Phase 1, Randomized, Open Label, Single Dose, 2-period Crossover Study To Evaluate Food Effect On The Pharmacokinetics Of Pf-04136309 In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04136309


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects of non childbearing potential, who at the time of screening are between the ages of 45 55, and/or male subjects 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 measurement, 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: Subjects who are smoking, or with evidence of disease, conditions affecting absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, use of prescription, nonprescription drugs and dietary supplement within 7 days, or blood donation of 500 mL within 56 days

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>All subjects will receive 2 treatments in one of the indicated sequence orders: A - B B - A | Drug: PF-04136309<br>* Treatment A (n=18): a single dose of 1000 mg PF 04136309 will be administered in a fasted state as 8 × 125 mg Tablets. Treatment B (n=18): a single dose of 1000 mg PF-04136309 will be administered with a high fat breakfast as 8 × 125 mg Tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve from time Zero to Extrapolated Infinite Time (AUC[0-inf]). | AUC(0-inf)=Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (o-inf). It is obtained from AUC (0-t) plus AUC (t-inf). | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours (hrs) post-PF-04136309 dose | 
| Maximum Plasma Concentration [Cmax] |  | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast). | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 | 
| Time to Reach maximum Observed Plasma Concentration (Tmax) | Time for Cmax | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose | 
| Plasma Decay Half Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 | 
| Apparent Oral Clearance (CL/F) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post-PF-04136309 dose | 
| Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food effect, healthy volunteers, pharmacokinetics, CCR2i