Food Effect Study for PF-06372865

Study Overview
=================
Brief Summary
-----------------
This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.

Official Title
-----------------
A Phase 1, Cross-over, Randomized, Single-dose Open Label Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered Pf-06372865 In Healthy Adult Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PF-06372865
* Drug: PF-06372865


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects of non-childbearing potential between the ages of 18 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: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease Screening supine blood pressure > 140 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest. Any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fasted condition<br> | Drug: PF-06372865<br>* 7.5 mg as 3 x 2.5 mg tablets single dose<br>|
| Other: fed condition<br> | Drug: PF-06372865<br>* 7.5 mg as 3 x 2.5 mg tablets single dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | basline to 48 hours | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | basline to 48 hours | 
| Maximum Observed Plasma Concentration (Cmax) |  | basline to 48 hours | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | basline to 48 hours | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | basline to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Systolic Blood Pressure | Value at time T minus value at baseline. | basline to 48 hours | 
| Change from Baseline in Diastolic Blood Pressure | Value at time T minus value at baseline. | basline to 48 hours | 
| Change from baseline in heart rate | value at time T minus value at baseline | basline to 48 hours |