AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

Study Overview
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Brief Summary
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Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.

Official Title
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A Phase 1, Open Label, Single Dose 3 Way Crossover Study to Evaluate the Bioavailability of a Solid Dose Formulation of PF 04965842 Relative to a Suspension Formulation Under Fasting Conditions and the Effect of Food on the Bioavailability of the Solid Dosage Formulation of Pf 04965842 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04965842
* Drug: PF-04965842
* Drug: PF- 04965842


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects and 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: Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem. Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.

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: Treatment A<br> | Drug: PF-04965842<br>* Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions<br>|
| Experimental: Treatment B<br> | Drug: PF-04965842<br>* Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions<br>|
| Experimental: Treatment C<br> | Drug: PF- 04965842<br>* Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions<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 infinity (AUC inf) |  | 15 days | 
| Maximum Observed Plasma Concentration (Cmax) |  | 15 days | 
| 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) | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 15 days | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Open Label, Single dose, Crossover, Bioavailability, Fasting, Fed, PF-04965842, Healthy