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
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
1 other identifier
interventional
5
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started May 2014
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedSeptember 25, 2014
September 1, 2014
3 months
April 8, 2014
September 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Cohort 1: PF-06372865 10 mg
EXPERIMENTALCohort 2: PF-06372865 TBD dose
EXPERIMENTALCohort 3: PF-06372865 TBD dose
EXPERIMENTALInterventions
Single, oral dose administration of 10 mg PF-06372865 using tablet formulation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Anlyan Center
New Haven, Connecticut, 06519, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2014
First Posted
May 14, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
September 25, 2014
Record last verified: 2014-09