The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
45
SGS Stuivenberg
Antwerp, Belgium
Occurrence of adverse events
At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.
Time frame: Daily during treatment, up to 10 days postdose
Evaluation of hematological, biochemical and cardiovascular parameters.
On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.
Time frame: until 10 days postdose.
Pharmacokinetics of repeated doses
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: 24 hours postdose
Pharmacodynamics (PD) of GLPG0778
To explore biomarkers of GLPG0778 activity after repeated oral administrations.
Time frame: up to 10 days postdose
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