A Phase 1 interventional study of GLPG0492 and placebo in Healthy, sponsored by Galapagos NV. Completed at 1 site in Belgium. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Galapagos NV · Phase 1, Interventional, and Other
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.
Galapagos NV is the lead sponsor of 103 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
single ascending doses
Drug: GLPG0492
single dose placebo
Drug: placebo
single dose, oral solution, 50 mg
Drug: GLPG0492
single dose, capsules (fasting)
Drug: GLPG0492
single dose, capsules (fed)
Drug: GLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
single dose, oral solution
single dose, solid formulation, 50 mg (2\*25 mg/capsule), fasting
single dose, solid formulation, 50 mg (2\*25 mg/capsule), after high fat breakfast
Safety and tolerability of single ascending doses in healthy young and elderly subjects.
Time frame: up to 10 days postdose
Pharmacokinetics of single oral doses (solution) in young and elderly subjects.
Time frame: 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.
Time frame: up to 10 days postdose
Determine the maximum tolerated dose in young subjects.
Time frame: Up to 10 days postdose
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Galapagos NV