Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg, 10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
CIM-Sant Pau - IIB Sant Pau, HSCSP
Barcelona, Barcelona, Spain
Palobiofarma S.L. (molecule owner)
Mataró, Barcelona, Spain
Number of Participants with Serious and Non-Serious Adverse Events
Vital Signs, ECG recordings, laboratory safety test and physical examination will be performed
Time frame: day 0 to day 7
Pharmacokinetic Profile Analysis (Plasma concentrations)
Baseline \[pre-dose\], \[+ 10 min\], \[+ 20 min\], \[+ 40 min\], \[+ 60 min\], \[+ 1.5h\], \[+ 2 h\], \[+ 2.5 h\], \[+ 3 h\], \[+ 4h\], \[+ 8h\], \[+ 12h\], \[+16h\] and \[+ 24h\] post-medication
Time frame: day 1
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