The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737 given for 14 days in healthy women of non-childbearing potential. The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for each compound.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
81
GLPG3067 oral suspension, single ascending doses, daily
Placebo, oral suspension, daily
GLPG3067 oral suspension, multiple ascending doses, daily for 14 days
Placebo, oral suspension, daily for 14 days
GLPG3067 oral suspension, single dose, daily
GLPG3067 oral tablet, single dose, daily
GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days
GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days
GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days
GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days
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, multiple ascending doses of GLPG3067 alone, or in combination with GLPG2222, or in combination with GLPG2222 and GLPG2737 versus placebo in healthy subjects
Time frame: Between screening and 14 days after the last dose
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
To characterize pharmacokinetics of GLPG3067 after a single oral dose and of GLPG3067, GLPG2222, and GLPG2737 after multiple oral doses in healthy subjects
Time frame: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737
To characterize pharmacokinetics of GLPG3067 after a single oral dose and of GLPG3067, GLPG2222, and GLPG2737 after multiple oral doses in healthy subjects
Time frame: Between Day 1 predose and 10 days after the last dose
Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects
To assess the potential for CYP3A4 interaction with GLPG3067, GLPG3067 and GLPG2222, or GLPG3067 and GLPG2222 and GLPG2737
Time frame: Day 1 predose and Day 14
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fed state
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Time frame: Between Day 1 predose and 10 days after the last dose
Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fed state
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Time frame: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fed state
To assess the relative bioavailability of GLPG3067 when given as a single dose of oral suspension or an oral tablet both administered in fed state
Time frame: Between Day 1 predose and 10 days after the last dose
Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fasted state
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Time frame: Between Day 1 predose and 10 days after the last dose
Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fasted state
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Time frame: Between Day 1 predose and 10 days after the last dose
Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone in fasted state
To assess the effect of food on the pharmacokinetics of GLPG3067 when given under fasted versus fed conditions
Time frame: Between Day 1 predose and 10 days after the last dose
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