This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
31
GLPG3121 oral suspension, single ascending doses
Placebo oral suspension
GLPG3121 oral suspension, multiple ascending doses, daily for 13 days
SGS Belgium NV - Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
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 and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects compared with placebo.
Time frame: From screening through study completion, an average of 6 months.
Maximum observed plasma concentration (Cmax) of GLPG3121 (μg/mL)
To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects
Time frame: Between Day 1 pre-dose and Day 16
Area under curve (AUC) of GLPG3121 (μg.h/mL)
To evaluate the PK of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects
Time frame: Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3121 (h)
To evaluate the PK of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects
Time frame: Between Day 1 pre-dose and Day 16
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Placebo oral suspension, daily for 13 days