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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05212377

• Registration Number: NCT02005991
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-09
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-15
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-05212377 70 mg	PF-05212377	-
PF-05212377 20 mg	PF-05212377	-
PF-05212377 10 mg	PF-05212377	-

Primary Outcome Measures

Name	Time	Method
5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET	Days 1 and 2
Plasma PF-05212377 exposure associated with PF-05212377 5-HT2a receptor occupancy	Days 1 and 2

Secondary Outcome Measures

Name	Time	Method
5-HT2a receptor occupancy of PF-05212377 in other cortical regions	Day 1 and 2

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States