A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers

Study Overview
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Brief Summary
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This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.

Official Title
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A Phase 1, Open-label Adaptive Design Study To Evaluate Pde10 Enzyme Occupancy As Measured By Positron Emission Tomography (Pet) Following Single Oral Dose Administration Of Pf-02545920 In Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: 20 mg PF-02545920
* Drug: PF-02545920
* Drug: PF-02545920


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male volunteers Exclusion Criteria: History of orthostatic hypotension History of prior radiation exposure for research purposes, or radiation therapy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 - 20 mg<br>Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920. | Drug: 20 mg PF-02545920<br>* Subject will receive a single dose of 20 mg PF-02545920.<br>|
| Experimental: Cohort 2 ( adaptive dose, optional)<br>Cohort 2 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1. | Drug: PF-02545920<br>* The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional.<br>|
| Experimental: Cohort 3 ( adaptive dose, optional)<br>Cohort 3 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional | Drug: PF-02545920<br>* The dose will be selected based on the results obtained for Cohort 1 and cohort 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central PDE10A enzyme occupancy values in the striatum. | Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, the central PDE10A enzyme occupancy values will be measured in the striatum at different single oral doses of PF-02545920. | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen (separately). | Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen be measured (separately) at different single oral doses of PF-02545920. | Day 10 | 
| Maximum Observed Plasma Concentration (Cmax) | Cmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan. | Day 10 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan. | Day 10 | 
| Average serum concentration | Average serum 02545920 during the post-dose positron emission tomography (PET) scan. | Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enzyme occupancy, PET, Phosphodiesterase 10 inhibitor