NCT02005991CompletedPhase 1
A Phase 1, Open-Label Study To Evaluate 5-HT2a Receptor Occupancy As Measured By Positron Emission Tomography (PET) With Ligand [11C]MDL100907 Following Single Oral Dose Administration Of PP-05212377 (SAM-760) In Healthy Subjects
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- 5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET
Study Overview
Brief Summary
This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's Disease, distributes in the brain after one dose of PF-05212377 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males and females must be at least 18 years of age and no older than 55 years of age with a Body Mass Index (BMI) must be between 17.5 and 30.
- •Subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures.
Exclusion Criteria
- •Females must not be pregnant, breastfeeding, or able to have children.
- •Subjects must not have a severe acute or chronic medical or psychiatric condition history or evidence of blood, kidney, glandular, lung, stomach, intestine, heart, blood vessel, liver, psychiatric, nerve, or allergic problems (including drug allergies), except mild seasonal allergies.
- •Subjects must not drink alcohol excessively or take illicit drugs.
- •Male subjects use condoms to prevent the potential transfer of drug through the semen to their partner beginning with the dose of study drug and use a highly effective method of birth control with any partner(s) of childbearing potential through 28 days after the last dose.
Arms & Interventions
PF-05212377 70 mg
Experimental
Intervention: PF-05212377 (Drug)
PF-05212377 20 mg
Experimental
Intervention: PF-05212377 (Drug)
PF-05212377 10 mg
Experimental
Intervention: PF-05212377 (Drug)
Outcomes
Primary Outcomes
5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET
Time Frame: Days 1 and 2
Plasma PF-05212377 exposure associated with PF-05212377 5-HT2a receptor occupancy
Time Frame: Days 1 and 2
Secondary Outcomes
- 5-HT2a receptor occupancy of PF-05212377 in other cortical regions(Day 1 and 2)
Investigators
Study Sites (1)
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