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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06372865

• Registration Number: NCT02138500
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-08
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-23
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: PF-06372865 10 mg	PF-06372865	-
Cohort 2: PF-06372865 TBD dose	PF-06372865	-
Cohort 3: PF-06372865 TBD dose	PF-06372865	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States

Anlyan Center; 🇺🇸 New Haven, Connecticut, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States