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Trial record 1 of 1 for:    NCT02124213
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A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers (PET)

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ClinicalTrials.gov Identifier: NCT02124213
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE April 28, 2014
Last Update Posted Date December 17, 2014
Study Start Date  ICMJE September 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
PF-06142562 plasma exposure and RO in the striatum [ Time Frame: Day 1 ]
Using Positron Emission Tomography and a radiotracer [11C]SCH23390, the PF-06142562 plasma exposure and RO in the striatum (average of caudate and putamen) will be measured in healthy male subjects.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 1 ]
  • Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4) [ Time Frame: Day 1 ]
  • Average plasma concentration over 4 hours (Cav,0-4) [ Time Frame: Day 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 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: 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 Date October 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 Committee No
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 Center Pfizer
PRS Account Pfizer
Verification Date December 2014

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