Healthy
Conditions
Keywords
Safety, Tolerability, Pharmacokinetics, Bioavailability (solid vs solution, fasting vs fed), Young healthy subjects, Elderly healthy subjects
Brief summary
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.
Interventions
DRUGGLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
DRUGplacebo
single dose, oral solution
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects) * BMI between 18-30 kg/m², inclusive * non-smoker
Exclusion criteria
* elevated PSA * drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of single ascending doses in healthy young and elderly subjects. | up to 10 days postdose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of single oral doses (solution) in young and elderly subjects. | up to 10 days postdose |
| Determine oral bioavailability of GLPG0492 given to elderly subjects as oral solution or solid dosage form with or without food. | up to 10 days postdose |
| Determine the maximum tolerated dose in young subjects. | Up to 10 days postdose |
Countries
Belgium
Outcome results
None listed