Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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