Healthy
Conditions
Brief summary
The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects. Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.
Interventions
DRUGGLPG0974
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 |
|---|---|---|
| The amount of GLPG0974 in plasma over time after a single oral dose | — | To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | — | 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 |
| Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974 | — | To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after a single oral dose in healthy subjects |
Countries
Belgium
Outcome results
None listed