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
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 11/8/2014 |
Start Date: | May 2014 |
End Date: | September 2014 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Phase 1, Open-Label Study To Evaluate Central Occupancy Of The Benzodiazepine Binding Site Of Gaba-A Receptors By Positron Emission Tomography (Pet) With Ligand [11c]Flumazenil Following Single Dose Of PF-06372865 In Healthy Subjects
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.
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.
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.
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