A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers
- Registration Number
- NCT02124213
- Lead Sponsor
- Pfizer
- Brief Summary
This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 2 ( adaptive dose, optional) PF-06412562 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. Cohor 1 - 30 mg 30 mg PF-06412562 Cohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562. Cohort 3 ( adaptive dose, optional) PF-06412562 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.
- Primary Outcome Measures
Name Time Method PF-06142562 plasma exposure and RO in the striatum 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.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Karolinska Trial Alliance (KTA) M62
🇸🇪Huddinge, Stockholm, Sweden