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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 November 13, 2019

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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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Descriptive Information
Brief Title  ICMJE A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers
Official Title  ICMJE 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
Brief SummaryThis study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • 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
Publications *Not Provided


*   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: December 16, 2014)
5
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2014)
15
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion DateOctober 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 20 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 NCT02124213
Other Study ID Numbers  ICMJE B7441005
2013-004356-37 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 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 the study website. Please see the references below:

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1-800-718-1021

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