The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
oral tablet, 1x, once a day in the morning for 14 days
oral tablet, 2x, once a day in the morning for 14 days
oral tablet, 3x, once a day in the morning for 14 days
Iberica Clinical Research Center
Eatontown, New Jersey, United States
Adverse Events
Time frame: from Screening through Day 18
Dose linearity of CHF5074 plasma levels (Cmax)
Time frame: Day -1 through Day 18
Dose linearity of CHF5074 plasma levels (AUC 0-t)
Time frame: Day -1 through Day 18
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oral tablet, placebo, once a day in the morning for 14 days