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

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NCT01918202

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Study Location
Karolinska Trial Alliance (KTA) M62
Huddinge, Stockholm, SE- 141 86, Sweden
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Contact
1-800-718-1021
[email protected]
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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers
Official Title  ICMJE 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
Brief Summary This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Delnomdedieu M, Forsberg A, Ogden A, Fazio P, Yu CR, Stenkrona P, Duvvuri S, David W, Al-Tawil N, Vitolo OV, Amini N, Nag S, Halldin C, Varrone A. In vivo measurement of PDE10A enzyme occupancy by positron emission tomography (PET) following single oral dose administration of PF-02545920 in healthy male subjects. Neuropharmacology. 2017 May 1;117:171-181. doi: 10.1016/j.neuropharm.2017.01.016. Epub 2017 Jan 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2014)		9
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2013)		12
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy male volunteers

Exclusion Criteria:

  • History of orthostatic hypotension
  • History of prior radiation exposure for research purposes, or radiation therapy
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01918202
Other Study ID Numbers  ICMJE A8241017
2013-002733-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP