Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GLPG0974 · 3 trials · 2 indications
To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported
To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported
To evaluate the safety and tolerability of GLPG0974 in terms of the changes in vital signs as measured by heart rate, blood pressure and oral temperature reported
To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported
To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported
To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported
To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects
| Arm | Type | Description |
|---|---|---|
| GLPG0974 | EXPERIMENTAL | 1 capsule of 200 mg GLPG0974 twice daily |
| Placebo | PLACEBO_COMPARATOR | 1 capsule placebo twice daily |
| 50 mg GLPG0974 or placebo | OTHER | 50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days |
| 100 mg GLPG0974 or placebo | OTHER | 100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days |
| 200 mg GLPG0974 or placebo | OTHER | 200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days |
| 400 mg GLPG0974 or placebo | OTHER | 400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days |
| GLPG0974 oral solution | EXPERIMENTAL | GLPG0974 oral solution |
| Placebo oral solution | PLACEBO_COMPARATOR | Placebo oral solution |
| Name | Type | Description |
|---|---|---|
| GLPG0974 | DRUG | 1 capsule in the morning and 1 capsule in the evening with food during 28 days |
| Placebo | DRUG | 1 capsule in the morning and 1 capsule in the evening with food during 28 days |
Key Inclusion Criteria: * Men or women between 18 to 75 years of age inclusive, on the day of signing the informed consent with a documented history of UC. * Presence of mild-to-moderately active ulcerative colitis as evidenced by clinical signs and endoscopy. * Medication: 5-ASA. * Absence of infe...
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