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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1: PF-06372865 10 mg

Group Type EXPERIMENTAL

PF-06372865

Intervention Type DRUG

Single, oral dose administration of 10 mg PF-06372865 using tablet formulation.

Cohort 2: PF-06372865 TBD dose

Group Type EXPERIMENTAL

PF-06372865

Intervention Type DRUG

Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.

Cohort 3: PF-06372865 TBD dose

Group Type EXPERIMENTAL

PF-06372865

Intervention Type DRUG

Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.

Interventions

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PF-06372865

Single, oral dose administration of 10 mg PF-06372865 using tablet formulation.

Intervention Type DRUG

PF-06372865

Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.

Intervention Type DRUG

PF-06372865

Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes