The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GLPG4059 in healthy volunteers after single oral administrations of GLPG4059 (SAD), compared to placebo (part 1). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics and relative bioavailability (rBA) of GLPG4059 will be assessed (part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
32
GLPG4059 for oral administration
Placebo oral suspension
GLPG4059 for oral administration
PRA Health Sciences
Groningen, Netherlands
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of single ascending oral doses of GLPG4059, in adult, healthy, male subjects compared with placebo.
Time frame: From screening through study completion, an average of 7 months
Maximum observed plasma concentration (Cmax) of GLPG4059
To evaluate the pharmacokinetics (PK) of single ascending oral doses of GLPG4059, in adult, healthy, male subjects.
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG4059
To evaluate the PK of single ascending oral doses of GLPG4059, in adult, healthy, male subjects
Time frame: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG4059
To evaluate the PK of single ascending oral doses of GLPG4059, in adult, healthy, male subjects
Time frame: Between Day 1 pre-dose and Day 4
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