Study Of The PF-04958242 Blood Concentrations Of A Capsule Formulation Of PF-04958242 Compared To A Solution Formulation

Study Overview
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Brief Summary
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This study will assess the relative bioavailability of a capsule formulation of PF-04958242, relative to a oral solution formulation of PF-04958242 in healthy adult subjects.

Detailed Description
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This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Official Title
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a Phase 1, Open-Label, Single Dose, Relative Bioavailability Study In Healthy Volunteers Comparing PF-04958242 Capsule Formulation To PF-04958242 Oral Solution In The Fasted State

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04958242 capsule
* Drug: PF-04958242 oral solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female (of non childbearing potential) subjects between the ages of 18 and 55 years 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 Any condition possibly affecting drug absorption (eg, gastrectomy).

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: PF-04958242 capsule<br> | Drug: PF-04958242 capsule<br>* Single dose of PF-04958242 0.35 mg oral capsule<br>|
| Active Comparator: PF-04958242 oral solution<br> | Drug: PF-04958242 oral solution<br>* Single dose of PF-04958242 0.35 mg oral solution<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 Last Quantifiable Concentration (AUClast) |  | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04958242 |  | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |  | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | 
| Plasma Decay Half-Life (t1/2) |  | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | 
| Apparent Oral Clearance (CL/F) |  | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | 
| Apparent Volume of Distribution (Vz/F) |  | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | 
| Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) |  | 4 and 192 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no secondary endpoints |  | no secondary endpoints | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-04958242, bioequivalence, pharmacokinetics, Schizophrenia