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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02138500

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06372865 Drug: PF-06372865 Drug: PF-06372865	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Cohort 1: PF-06372865 10 mg

Drug: PF-06372865

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

Experimental: Cohort 2: PF-06372865 TBD dose

Drug: PF-06372865

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

Experimental: Cohort 3: PF-06372865 TBD dose

Drug: PF-06372865

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511
2	Anlyan Center	New Haven	Connecticut	United States	06519
3	Yale University School of Medicine	New Haven	Connecticut	United States	06520