The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451 given to healthy female subjects compared to placebo as well as of multiple doses of the combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
31
GLPG2451 oral suspension, single ascending doses, daily
Placebo, oral suspension, daily
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
Change versus placebo in the proportion of subjects with adverse events
To assess safety and tolerability of single ascending doses with GLPG2451 versus placebo in healthy subjects
Time frame: Between screening and 182 days after the last dose
Maximum observed plasma concentration of GLPG2451 (Cmax) given alone
To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
Time frame: Between day 1 predose and 175 days after the last dose
Time of occurrence of Cmax for GLPG2451 and (tmax) given alone
To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
Time frame: Between day 1 predose and 175 days after the last dose
Area under the plasma concentration-time curve (AUC0-t) of GLPG2451 given alone
To characterize pharmacokinetics of GLPG2451 and its metabolite after a single oral dose in healthy subjects
Time frame: Between day 1 predose and 175 days after the last dose
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