The purpose of this study is to determine the effect of the administration of multiple doses of GLPG4716 on the amount of midazolam (MDZ) that gets into the blood when the two drugs are administered together compared to when midazolam is administered alone. Other objectives of this study are to evaluate the safety and tolerability of GLPG4716 when administered with midazolam and assess the amount of GLPG4716 that gets into the blood when administered with midazolam. This study will also assess the effect of food on the amount of GLPG4716 that gets into the blood.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
19
Altasciences
Montreal, Canada
Maximum observed plasma concentration (Cmax) of MDZ
To determine the effect of GLPG4716 on the pharmacokinetics (PK) of MDZ
Time frame: From Day 1 pre-dose until Day 15
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MDZ
To determine the effect of GLPG4716 on the PK of MDZ
Time frame: From Day 1 pre-dose until Day 15
Cmax of GLPG4716
To assess the effect of food on the PK of GLPG4716.
Time frame: From Day 1 pre-dose until Day 15
Area under the plasma concentration-time curve over the dosing interval (AUCt) of GLPG4716
To assess the effect of food on the PK of GLPG4716.
Time frame: From Day 1 pre-dose until Day 15
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent (SAEs), and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of GLPG4716 when co-administered with MDZ
Time frame: From Day 1 through study completion, an average of one month
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