The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
100
GLPG3970 for oral administration
Placebo for oral administration
GLPG3970 for oral administration
SGS Belgium NV - Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
Clinical Republican Hospital Arensia Experimental Medicine
Chisinau, Moldova
ARENSIA Exploratory Medicine Unit
Kyiv, Ukraine
Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks
Time frame: From screening through study completion, an average of 20 months
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3970 in adult healthy male subjects
Time frame: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)
To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects
Time frame: Between Day 1 pre-dose and Day 17
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE)
To evaluate the food effect on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA)
To evaluate the PK of a single oral dose of GLPG3970 administered as an oral solution versus and oral capsule in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 1 and 1bis)
To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 2)
To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects
Time frame: Between Day 1 pre-dose and Day 17
Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE)
To evaluate the food effect on the PK of a single oral dose of GLPG3970 under fed conditions (high-fat high calorie) versus fasted conditions in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 3, rBA)
To evaluate the rBA of an oral solution of GLPG3970 versus an oral capsule of GLPG3970 on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis)
To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3970 (Part 2)
To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 17
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