This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
124
SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day
SAM-760 matching placebo capsule, single dose, 1 day,
Ketoconazole oral tablets, 200 mg bid, 14 days
Pfizer Investigational Site
Rueil-Malmaison, France, France
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: 5 days
Maximum concentration (Cmax) for PF-05212377 over time.
Time frame: 5 days
Measurement of Area Under the curve (AUC) for PF-05212377.
Time frame: 5 days
Time of maximum (Tmax) concentration of PF-05212377 in plasma.
Time frame: 5 days
Elimination half life (t1/2) of PF-05212377.
Time frame: 5 days
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