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Also known as GLPG0555 aqueous, GLPG0555 solid dispersion, GLPG0555 nanosuspension
GLPG0555 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| GLPG0555 solid dispersion, fasting | EXPERIMENTAL | 50 mg as solid dispersion capsule, in fasting condition |
| GLPG0555 solid dispersion, fed | EXPERIMENTAL | 50 mg as solid dispersion capsule, after breakfast |
| GLPG0555 nanosuspension, fed | EXPERIMENTAL | 50 mg as nanosuspension, given after breakfast |
| Aqueous formulations for formulation selection | EXPERIMENTAL | 50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation |
| GLPG0555 ascending doses | EXPERIMENTAL | multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily) |
| 3 | PLACEBO_COMPARATOR | once or twice daily for 13 days, matching the scheme of the multiple ascending dose. |
| 1 | EXPERIMENTAL | single ascending doses |
| 2 | PLACEBO_COMPARATOR | single dose placebo |
| 4 | PLACEBO_COMPARATOR | multiple dose, 7 or 14 days, oral solution |
| Name | Type | Description |
|---|---|---|
| GLPG0555 solid dispersion | DRUG | solid dispersion capsules, 50 mg, single dose |
| GLPG0555 nanosuspension | DRUG | Nanosuspension, 50 mg, single dose |
| GLPG0555 | DRUG | two different aqueous formulations |
| GLPG0555 aqueous | DRUG | multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined |
| placebo | DRUG | multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule |
Inclusion Criteria: * healthy male * BMI between 18-30 kg/m², inclusive. Exclusion Criteria: * significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse
GLPG0555 is an investigational small molecule drug developed by Lakefront Biotherapeutics. It is a JAK1-targeting kinase inhibitor that has been studied in Phase 1 clinical trials in healthy volunteers. The specific therapeutic indications for GLPG0555 have not been disclosed.
GLPG0555 targets JAK1, a kinase enzyme. As a small molecule JAK1 inhibitor, GLPG0555 is designed to modulate JAK1-mediated signaling pathways. This mechanism places it within the kinase inhibitor class of therapeutic agents.
GLPG0555 is being developed by Lakefront Biotherapeutics, which trades under the ticker symbol LKFT. The company has sponsored all three Phase 1 clinical trials of GLPG0555 conducted to date.
GLPG0555 is in Phase 1 clinical development. All three of its clinical trials have been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
GLPG0555 has been evaluated in three completed Phase 1 trials: NCT01023321, a first-in-human single and multiple ascending dose study; NCT01208753, a pharmacokinetics and pharmacodynamics study of multiple oral doses; and NCT01278095, an oral bioavailability study of different solid formulations. All enrolled healthy male volunteers in Belgium.
Yes, GLPG0555 aqueous, GLPG0555 solid dispersion, and GLPG0555 nanosuspension are alternative names referring to different formulations of the same drug candidate, GLPG0555. These formulation variants were studied in a Phase 1 oral bioavailability trial comparing different solid formulations of the compound.