The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days
Pfizer Investigational Site
Utrecht, Netherlands
Maximum plasma concentration (Cmax)
Time frame: 24 days
Time to maximum plasma concentration (tmax)
Time frame: 24 days
Area under the concentration-time curve (AUC)
Time frame: 24 days
Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests
Time frame: 24 days
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