Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo. Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo. Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.
Interventions
DRUGGLPG0974
DRUGPlacebo
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male, age 18-50 years * BMI between 18-30 kg/m2
Exclusion criteria
* Any condition that might interfere with the procedures or tests in this study * Drug or alcohol abuse * Smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Between screening and 7-10 days after the last dose | To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of GLPG0974 in plasma and urine over time after multiple oral dose | Between Day 1 predose and Day 14 | To characterize the amount of GLPG0974 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects |
| Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974 | Day 1 and Day 13, predose until 24h post dose | To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after multiple oral doses in healthy subjects |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ratio of 6b-hydroxycortisol/cortisol in urine | Predose and postdose on Day 1 and Day 13 for 24h | Potential of CYP3A4 induction by repeated dosing with GLPG0974 will be assessed by means of the ratio of 6b-hydroxycortisol/cortisol in urine |
| Levels of faecal calprotectin in stool | Prior to first dosing and postdose (between Day 12 and 15) | Concentrations of faecal calprotectin will be measured as a pharmacodynamic marker in a single stool sample predose and postdose |
| Glucose and insulin concentrations after glucose loading | Day -1 (predose) and Day 14 (postdose) | Oral glucose tolerance test by means of measuring concentrations of glucose and insulin after glucose loading, once predosing and once postdosing of GLPG0974 |
Countries
Belgium
Outcome results
None listed