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A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers

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NCT01918202

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Karolinska Trial Alliance (KTA) M62
Huddinge, Stockholm, SE- 141 86 Sweden
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
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- healthy male volunteers

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

- History of orthostatic hypotension

- History of prior radiation exposure for research purposes, or radiation therapy

NCT01918202
Pfizer
Completed
A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers

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A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers
A Phase 1, Open-label Adaptive Design Study To Evaluate Pde10 Enzyme Occupancy As Measured By Positron Emission Tomography (Pet) Following Single Oral Dose Administration Of Pf-02545920 In Healthy Male Subjects
This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: 20 mg PF-02545920
    Subject will receive a single dose of 20 mg PF-02545920.
  • Drug: PF-02545920

    The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg.

    This cohort is optional.

  • Drug: PF-02545920
    The dose will be selected based on the results obtained for Cohort 1 and cohort 2.
  • Experimental: Cohort 1 - 20 mg
    Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920.
    Intervention: Drug: 20 mg PF-02545920
  • Experimental: Cohort 2 ( adaptive dose, optional)
    Cohort 2 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1.
    Intervention: Drug: PF-02545920
  • Experimental: Cohort 3 ( adaptive dose, optional)

    Cohort 3 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1.

    Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional

    Intervention: Drug: PF-02545920
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy male volunteers

Exclusion Criteria:

  • History of orthostatic hypotension
  • History of prior radiation exposure for research purposes, or radiation therapy
Sexes Eligible for Study: Male
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01918202
A8241017
2013-002733-38 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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