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

NCT02005991 | Completed Phase 1

• 1 other identifier: B2081015
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Keywords

PF-05212377; phase 1; open-label; 5-HT2a receptor occupancy; positron emission tomography; healthy subjects; brain; cortex; alzheimers disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 5-HT2a receptor occupancy of PF-05212377 in other cortical regions

  Day 1 and 2

Study Arms (3)

PF-05212377 70 mg

EXPERIMENTAL

Drug: PF-05212377

PF-05212377 20 mg

EXPERIMENTAL

Drug: PF-05212377

PF-05212377 10 mg

EXPERIMENTAL

Drug: PF-05212377

Interventions

PF-05212377 DRUG

Single, oral dose administration of 70 mg PF-0521377 using a capsule formulation.

PF-05212377 70 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06519, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06520, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

SAM-760

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: November 5, 2013
• First Posted: December 9, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

US (3)