A Study to Examine the Distribution of PF-06372865 in the Brain of Healthy Volunteers Using Positron Emission Tomography and a Radioactive Tracer Following Oral Administration of One Dose of PF-06372865

Study Overview
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Brief Summary
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This study will see how PF-06372865, an experimental drug distributes in the brain after one dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-06372865in these subjects and will measure the level of PF-06372865 in the blood.

Official Title
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A Phase 1, Open-label Study To Evaluate Central Occupancy Of The Benzodiazepine Binding Site Of Gabaa Receptors By Positron Emission Tomography (Pet) With Ligand [11c]Flumazenil Following Single Dose Of Pf-06372865 In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-06372865
* Drug: PF-06372865
* Drug: PF-06372865


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). Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy). Known or suspected sensitivity to flumazenil and other benzodiazepines.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: PF-06372865 10 mg<br> | Drug: PF-06372865<br>* Single, oral dose administration of 10 mg PF-06372865 using tablet formulation.<br>|
| Experimental: Cohort 2: PF-06372865 TBD dose<br> | Drug: PF-06372865<br>* Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.<br>|
| Experimental: Cohort 3: PF-06372865 TBD dose<br> | Drug: PF-06372865<br>* Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GABAA RO in the whole brain |  | Change from baseline to days 1 and 2 | 
| Average plasma concentration of PF-06372865 in post-dose PET scans after single oral doses of PF-06372865 |  | Change from baseline to days 1 and 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-06372865, phase 1, open-label, GABA-A receptor occupancy, positron emission tomography, healthy subjects