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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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NCT02005991

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02005991
Pfizer
Completed
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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[email protected]

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-05212377
    Single, oral dose administration of 70 mg PF-0521377 using a capsule formulation.
  • 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.
  • 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.
  • Experimental: PF-05212377 70 mg
    Intervention: Drug: PF-05212377
  • Experimental: PF-05212377 20 mg
    Intervention: Drug: PF-05212377
  • Experimental: PF-05212377 10 mg
    Intervention: Drug: PF-05212377
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
January 2014
January 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02005991
B2081015
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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