A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers

Study Overview
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Brief Summary
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This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers

Official Title
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Open Label Adaptive Design Study To Evaluate D1 Receptor Occupancy (ro) Following Single Dose Of Pf-06412562, Using Positron Emission Tomography (Pet) With Ligand [11c]sch23390 In Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: 30 mg PF-06412562
* Drug: PF-06412562
* Drug: PF-06412562


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Male Volunteers Exclusion Criteria: Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease Any condition possibly affecting drug absorption A positive urine drug screen

Ages Eligible for Study
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Minimum Age: 20 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohor 1 - 30 mg<br>Cohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562. | Drug: 30 mg PF-06412562<br>* Subject will receive a single dose of 30 mg PF-06412562<br>|
| Experimental: Cohort 2 ( adaptive dose, optional)<br>Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1. | Drug: PF-06412562<br>* The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.<br>|
| Experimental: Cohort 3 ( adaptive dose, optional)<br>Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1 and Cohort 2. | Drug: PF-06412562<br>* The dose will be selected based on the results obtained for Cohort 1 and Cohort 2. This Cohort is optional.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PF-06142562 plasma exposure and RO in the striatum | Using Positron Emission Tomography and a radiotracer [11C]SCH23390, the PF-06142562 plasma exposure and RO in the striatum (average of caudate and putamen) will be measured in healthy male subjects. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | Day 1 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | Day 1 | 
| Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4) |  | Day 1 | 
| Average plasma concentration over 4 hours (Cav,0-4) |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Receptor Occupancy, PET, D1 Receptor Agonist