This is a multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to healthy young adults and healthy elderly subjects. The study will be conducted under double-blind conditions (neither the investigator nor the subject will know if he/she has received PF-05212377 or a placebo). The Sponsor will know if the subject has received active treatment or a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
60
Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg
Oral capsule, once daily for 14 days
Pfizer Investigational Site
Rueil-Malmaison, France
Adverse events (spontaneous and solicited).
Time frame: 0-24days
Change from baseline in vital signs.
Time frame: 0-24 days
Change from baseline in triplicate ECGs.
Time frame: 0-24 days
Clinical safety laboratory endpoints, including a complete blood count, reticulocytes and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive.
Time frame: 0-24 days
Physical examinations and neurological examinations
Time frame: 0-24 days
Pharmacokinetics in young adults (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2).
Time frame: 0-21 days
Pharmacokinetics in elderly subjects (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2).
Time frame: 0-21 days
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