Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GLPG0778 · 2 trials · 1 indication
At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.
On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.
| Arm | Type | Description |
|---|---|---|
| GLPG0778 ascending doses | EXPERIMENTAL | Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation. |
| Placebo | PLACEBO_COMPARATOR | Twice daily for 13 days, matching the scheme of the multiple ascending dose. |
| 1 | EXPERIMENTAL | single ascending doses |
| 2 | PLACEBO_COMPARATOR | single dose placebo |
| 3 | EXPERIMENTAL | multiple dose, 7 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily). |
| 4 | PLACEBO_COMPARATOR | multiple dose, capsules, 7 days; scheme to match that of Study Arm 3. |
| Name | Type | Description |
|---|---|---|
| GLPG0778 | DRUG | capsules containing 50 or 100 mg of GLPG0778 |
| placebo | DRUG | multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule |
Inclusion Criteria: * healthy male, age 18-50 years * body mass index (BMI) between 18-30 kg/m², inclusive. Exclusion Criteria: * significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse * hypersensitivity to any of the test substances