A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.
Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
24
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Safety; ECGs/vital signs
Time frame: Screening to Follow-up (Day 5)
Safety; laboratory tests
Time frame: Screening to Follow-up (Day 5)
Safety; physical examination/adverse event monitoring
Time frame: Screening to Follow-up (Day 5)
Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations
Time frame: Day 1 to Day 3
Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations
Time frame: Day 1 to Day 3
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Two subjects will receive the placebo under fasting condition.
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
Two subjects will receive the placebo under fasting condition.