A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers
PET
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
2 other identifiers
interventional
5
1 country
1
Brief Summary
This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Sep 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 28, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 17, 2014
December 1, 2014
1 month
April 24, 2014
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PF-06142562 plasma exposure and RO in the striatum
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.
Day 1
Secondary Outcomes (4)
Maximum Observed Plasma Concentration (Cmax)
Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Day 1
Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4)
Day 1
Average plasma concentration over 4 hours (Cav,0-4)
Day 1
Study Arms (3)
Cohor 1 - 30 mg
EXPERIMENTALCohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562.
Cohort 2 ( adaptive dose, optional)
EXPERIMENTALCohort 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.
Cohort 3 ( adaptive dose, optional)
EXPERIMENTALCohort 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.
Interventions
The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.
Eligibility Criteria
You may qualify if:
- Healthy Male Volunteers
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Karolinska Trial Alliance (KTA) M62
Huddinge, Stockholm County, SE- 141 86, Sweden
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2014
First Posted
April 28, 2014
Study Start
September 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 17, 2014
Record last verified: 2014-12