Healthy
Conditions
Keywords
Healthy Volunteers
Brief summary
The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-04995274 in healthy volunteers.
Interventions
DRUGPF-04995274
Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening * Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exposure response of overall 5HT4 receptor occupancy of PF-04995274 | up to 3 days |
| 5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain | up to 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Singlet ECG post-dose | up to 3 days |
| Clinical safety laboratory endpoints | up to 3 days |
| Adverse events | up to 3 days |
| Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma | up to 3 days |
| Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma | up to 3 days |
| Clinical examinations | up to 3 days |
| change from baseline in vital signs | up to 3 days |
Countries
United States
Outcome results
None listed