Healthy
Conditions
Keywords
Receptor Occupancy, PET, D1 Receptor Agonist
Brief summary
This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers
Interventions
DRUG30 mg PF-06412562
Subject will receive a single dose of 30 mg PF-06412562
DRUGPF-06412562
The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Average plasma concentration over 4 hours (Cav,0-4) | Day 1 |
| 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 |
Countries
Sweden
Outcome results
None listed