The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food). Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
48
SGS Stuivenberg
Antwerp, Belgium
Safety and tolerability of single and multiple dosing
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.
Time frame: up to 10 days postdose
Pharmacokinetics of single and repeated doses, including effect of food.
Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism).
Time frame: up to 10 days postdose
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multiple dose, capsule, 10 days