Healthy
Conditions
Keywords
Safety, Tolerability, Pharmacokinetics
Brief summary
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.
Interventions
DRUGGLPG0555
two different aqueous formulations
DRUGGLPG0555 aqueous
multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined
DRUGplacebo
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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, inclusive.
Exclusion criteria
* significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of multiple dosing | Daily during treatment, up to 10 days postdose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of repeated doses | 24 hours postdose |
| Pharmacodynamics (PD) of GLPG0555 after repeated oral administration | up to 10 days postdose |
| The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days | up to 24 hours postdose |
Countries
Belgium
Outcome results
None listed