A Study To Examine The Distribution Of PF-05212377 In The Brain Of Healthy Volunteer Subjects Using Positron Emission Tomography And A Radioactive Tracer Following Oral Administration Of One Dose Of PF-05212377

Study Overview
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Brief Summary
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This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's Disease, distributes in the brain after one dose of PF-05212377 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.

Official Title
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A Phase 1, Open-Label Study To Evaluate 5-HT2a Receptor Occupancy As Measured By Positron Emission Tomography (PET) With Ligand [11C]MDL100907 Following Single Oral Dose Administration Of PP-05212377 (SAM-760) In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-05212377
* Drug: PF-05212377
* Drug: PF-05212377


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females must be at least 18 years of age and no older than 55 years of age with a Body Mass Index (BMI) must be between 17.5 and 30.5. Subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures. Exclusion Criteria: Females must not be pregnant, breastfeeding, or able to have children. Subjects must not have a severe acute or chronic medical or psychiatric condition history or evidence of blood, kidney, glandular, lung, stomach, intestine, heart, blood vessel, liver, psychiatric, nerve, or allergic problems (including drug allergies), except mild seasonal allergies. Subjects must not drink alcohol excessively or take illicit drugs. Male subjects use condoms to prevent the potential transfer of drug through the semen to their partner beginning with the dose of study drug and use a highly effective method of birth control with any partner(s) of childbearing potential through 28 days after the last dose.

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: PF-05212377 70 mg<br> | Drug: PF-05212377<br>* Single, oral dose administration of 70 mg PF-0521377 using a capsule formulation.<br>|
| Experimental: PF-05212377 20 mg<br> | Drug: PF-05212377<br>* Single, oral dose administration of 20 mg PF-0521377 using a capsule formulation. This dose is an estimate. The exact dose for Arm 2 will be based on the results from Arm 1.<br>|
| Experimental: PF-05212377 10 mg<br> | Drug: PF-05212377<br>* Single, oral dose administration of 10 mg PF-0521377 using a capsule formulation. This dose is an estimate. The exact dose for Arm 2 will be based on the results from Arms 1 and 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET |  | Days 1 and 2 | 
| Plasma PF-05212377 exposure associated with PF-05212377 5-HT2a receptor occupancy |  | Days 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-HT2a receptor occupancy of PF-05212377 in other cortical regions |  | Day 1 and 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-05212377, phase 1, open-label, 5-HT2a receptor occupancy, positron emission tomography, healthy subjects, brain, cortex, alzheimers disease