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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

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ClinicalTrials.gov Identifier: NCT02005991
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-05212377 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : November 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-05212377 70 mg Drug: PF-05212377
Single, oral dose administration of 70 mg PF-0521377 using a capsule formulation.

Experimental: PF-05212377 20 mg Drug: PF-05212377
Single, oral dose administration of 20 mg PF-0521377 using a capsule formulation. This dose is an estimate. The exact dose for Arm 2 will be based on the results from Arm 1.

Experimental: PF-05212377 10 mg Drug: PF-05212377
Single, oral dose administration of 10 mg PF-0521377 using a capsule formulation. This dose is an estimate. The exact dose for Arm 2 will be based on the results from Arms 1 and 2.




Primary Outcome Measures :
  1. 5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET [ Time Frame: Days 1 and 2 ]
  2. Plasma PF-05212377 exposure associated with PF-05212377 5-HT2a receptor occupancy [ Time Frame: Days 1 and 2 ]

Secondary Outcome Measures :
  1. 5-HT2a receptor occupancy of PF-05212377 in other cortical regions [ Time Frame: Day 1 and 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005991


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02005991     History of Changes
Other Study ID Numbers: B2081015
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014

Keywords provided by Pfizer:
PF-05212377
phase 1
open-label
5-HT2a receptor occupancy
positron emission tomography
healthy subjects
brain
cortex
alzheimers disease