A Study To Examine The Distribution Of PF-05212377 In The Brain Of Healthy Volunteer Subjects Using Positron Emission Tomography And A Radioactive Tracer Following Oral Administration Of One Dose Of PF-05212377
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/1/2014 |
| Start Date: | November 2013 |
| End Date: | April 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
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
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.
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.
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 30.5.
- 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.
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