A Phase 1, Open-Label Study To Evaluate 5-HT6 Receptor Occupancy As Measured By Positron Emission Tomography (PET) With Ligand [11C]PF-04171252 Following Single Oral Dose Administration Of PF-05212365 (SAM-531) In Healthy Subjects

简要总结

主要结局

次要结局

• Abnormal findings from standard physical examination(Baseline and 72 hrs post-dose)
• Maximum concentration (Cmax) for PF-05212365 in plasma(up to 4 days)
• Time at Cmax (Tmax) for PF-05212365 in plasma(up to 4 days)
• Number of Participants with Adverse Events as a Measure of Safety and Tolerability(continuous, up to 4 days)
• Change from baseline in orthostatic blood pressure(Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose)
• Change from baseline in supine blood pressure(Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose)
• Change from baseline in Singlet ECG(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).(Baseline and 72 hrs post-dose)
• Area under the concentration-time profile from time zero to the time of the last quantifiableconcentration (AUClast) for PF-05212365 in plasma(up to 4 days)
• Average concentration during the first post-dose PET scan (Cavg (scan 1)) for PF-05212365 in plasma(2-4 hrs post-dose)
• Average concentration during the second post-dose PET scan (Cavg (scan 2)) for PF-05212365 in plasma(48-50 hrs post dose)
• Change from baseline in orthostatic pulse rate(Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose)
• Change from baseline in supine pulse rate(Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose)
• Abnormal findings from standard neurological examination(Baseline and 72 hrs post-dose)