A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers
NCT ID: NCT01918202
Last Updated: 2014-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2014-03-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1 - 20 mg
Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920.
20 mg PF-02545920
Subject will receive a single dose of 20 mg PF-02545920.
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.
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.
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
PF-02545920
The dose will be selected based on the results obtained for Cohort 1 and cohort 2.
Interventions
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20 mg PF-02545920
Subject will receive a single dose of 20 mg PF-02545920.
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.
PF-02545920
The dose will be selected based on the results obtained for Cohort 1 and cohort 2.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of prior radiation exposure for research purposes, or radiation therapy
21 Years
55 Years
MALE
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Karolinska Trial Alliance (KTA) M62
Huddinge, Stockholm County, Sweden
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-002733-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8241017
Identifier Type: -
Identifier Source: org_study_id