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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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-05212377

Study type

Interventional

Funder types

Industry

Identifiers

NCT02005991
B2081015

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4 participants in 3 patient groups

PF-05212377 70 mg
Experimental group
Treatment:
Drug: PF-05212377
Drug: PF-05212377
Drug: PF-05212377
PF-05212377 20 mg
Experimental group
Treatment:
Drug: PF-05212377
Drug: PF-05212377
Drug: PF-05212377
PF-05212377 10 mg
Experimental group
Treatment:
Drug: PF-05212377
Drug: PF-05212377
Drug: PF-05212377

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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