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A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Karolinska Trial Alliance (KTA) M62
Huddinge, Stockholm, SE- 141 86 Sweden
Contact
1-800-718-1021
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
20-55 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

Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine,
hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic
disease Any condition possibly affecting drug absorption A positive urine drug screen

NCT02124213
Pfizer
Completed
A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers

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A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers
Open Label Adaptive Design Study To Evaluate D1 Receptor Occupancy (ro) Following Single Dose Of Pf-06412562, Using Positron Emission Tomography (Pet) With Ligand [11c]sch23390 In Healthy Male Subjects
This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: 30 mg PF-06412562
    Subject will receive a single dose of 30 mg PF-06412562
  • Drug: PF-06412562
    The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.
  • Drug: PF-06412562

    The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.

    This Cohort is optional.

  • Experimental: Cohor 1 - 30 mg
    Cohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562.
    Intervention: Drug: 30 mg PF-06412562
  • Experimental: Cohort 2 ( adaptive dose, optional)
    Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1.
    Intervention: Drug: PF-06412562
  • Experimental: Cohort 3 ( adaptive dose, optional)
    Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.
    Intervention: Drug: PF-06412562
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy Male Volunteers

Exclusion Criteria:

Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease Any condition possibly affecting drug absorption A positive urine drug screen

Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT02124213
B7441005
2013-004356-37 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 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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