This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
52
GLPG3667 oral suspension
Placebo oral suspension
GLPG3667 capsules
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 GLPG3667, in adult, healthy, male subjects compared with placebo
Time frame: From screening through study completion, an average of 5 months
Maximum observed plasma concentration (Cmax) of GLPG3667 (μg/mL)
To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects
Time frame: Between Day 1 pre-dose and Day 16
Area under curve (AUC) of GLPG3667 (μg.h/mL)
To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects
Time frame: Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3667 (h)
To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects
Time frame: Between Day 1 pre-dose and Day 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.