Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01208753 | Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2010 | Feb 1, 2011 | Mar 23, 2011 | 1 | Belgium |
| NCT01023321 | First-in-Human Single Ascending and Multiple Dose of GLPG0555 | PHASE1 | COMPLETED | 35 | — | — | Dec 1, 2009 | May 1, 2010 | Aug 12, 2010 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| 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 | 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, age 18-50 years * BMI between 18-30 kg/m², inclusive. Exclusion Criteria: * significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse