A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions

Study Overview
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Brief Summary
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The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.

Official Title
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A Phase 1, Open-label Study In Healthy Subjects To Investigate the Pharmacokinetics Of Pf-06412562 Following Single Oral Administration Of Modified Release Formulation In Fasted And Fed States

Conditions
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Healthy

Intervention / Treatment
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* Drug: 3 mg PF-06412562 MR tablets_Fasted
* Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted
* Drug: 2 x 15 mg PF-06412562 MR tablets_Fed
* Drug: 10 mg PF-06412562 IR tablets


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 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: 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. Subjects who have attempted suicide in the past. Subjects who have an unexplained history of sudden death in their family

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: Arm 1<br> | Drug: 3 mg PF-06412562 MR tablets_Fasted<br>* A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast<br>|
| Experimental: 2<br> | Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted<br>* Two 15 mg PF-06412562 modified release tablets administered after an overnight fast<br>|
| Experimental: 3<br> | Drug: 2 x 15 mg PF-06412562 MR tablets_Fed<br>* Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast<br>|
| Experimental: 4<br> | Drug: 10 mg PF-06412562 IR tablets<br>* a single immediate release tablet of 10 mg PF-06412562 after an overnight fast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | 0-2 days | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0-2 days | 
| Time after dose and before the first plasma concentration (Tlag) |  | 0-2 | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf). | 0- 2 days | 
| 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) | 0-2 days | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relative bioavailbility, food effect, pharmacokinetics, ALTERATION OF COGNITIVE FUNCTIONS