A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the bioavailability, safety, and tolerability of a modified-release formulation of PF-05180999 relative to an immediate-release formulation in healthy adult subjects. Two doses of the modified-release formulation and one dose of the immediate-release formulation will be evaluated under fasted conditions. One dose of the modified-release formulation will also be evaluated in the presence of food.

Official Title
-----------------
A Phase 1, Cross-Over, Single-Dose, Open-Label Study to Estimate the Relative Bioavailability of a Modified-Release Formulation of PF-05180999 Under Fed and Fasted Conditions in Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: PF-05180999
* Drug: PF-05180999
* Drug: PF-05180999
* Drug: PF-05180999


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of non-childbearing potential Exclusion Criteria: Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption

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 |
| --- | --- |
| Experimental: PF-05180999 Immediate-Release<br> | Drug: PF-05180999<br>* Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation<br>|
| Experimental: PF-05180999 Modified-Release 1<br> | Drug: PF-05180999<br>* Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation<br>|
| Experimental: PF-05180999 Modified-Release 2<br> | Drug: PF-05180999<br>* Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation<br>|
| Experimental: PF-05180999 Modified-Release 1 With Food<br> | Drug: PF-05180999<br>* Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period | 
| Plasma Decay Half-Life (t1/2) |  | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |  | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PF-05180999, safety, pharmacokinetics, relative bioavailability, Mental Disorders, Schizophrenia and Disorders with Psychotic Features, Schizophrenia