A Phase 1 interventional study of PF-05212365 in Healthy, sponsored by Pfizer. Completed at 3 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-28.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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-05212365 in healthy volunteers
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PF-05212365
Single dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1.
Also known as: SAM-531
Exposure response of 5-HT6 Receptor Occupancy (RO) of PF-05212365 in the striatum of healthy adult subjects
Time frame: up to 4 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: continuous, up to 4 days
Change from baseline in orthostatic blood pressure
Time frame: Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose
Change from baseline in supine blood pressure
Time frame: Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose
Change from baseline in Singlet ECG
Time frame: Baseline and 72 hrs post-dose
Clinically relevant levels of standard hemotology (e.g. Hemoglobin, Hematocrit RBC count), chemistry (e.g. BUN, Creatinine, fasting Glucose), and urinalysis (e.g. pH Glucose, Protein).
Time frame: Baseline and 72 hrs post-dose
Abnormal findings from standard physical examination
Time frame: Baseline and 72 hrs post-dose
Maximum concentration (Cmax) for PF-05212365 in plasma
Time frame: up to 4 days
Time at Cmax (Tmax) for PF-05212365 in plasma
Time frame: up to 4 days
Area under the concentration-time profile from time zero to the time of the last quantifiableconcentration (AUClast) for PF-05212365 in plasma
Time frame: up to 4 days
Average concentration during the first post-dose PET scan (Cavg (scan 1)) for PF-05212365 in plasma
Time frame: 2-4 hrs post-dose
Average concentration during the second post-dose PET scan (Cavg (scan 2)) for PF-05212365 in plasma
Time frame: 48-50 hrs post dose
Change from baseline in orthostatic pulse rate
Time frame: Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose
Change from baseline in supine pulse rate
Time frame: Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose
Abnormal findings from standard neurological examination
Time frame: Baseline and 72 hrs post-dose
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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