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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03800472 | A Study Investigating the Safety, Absorption and Elimination of GLPG3312, a New Drug in the Treatment of Inflammatory Diseases | PHASE1 | COMPLETED | 95 | — | — | Jan 15, 2019 | Mar 10, 2020 | Mar 19, 2020 | 1 | Netherlands |
To evaluate the safety and tolerability of oral single and multiple ascending doses of GLPG3312, in adult, healthy, subjects, when given as Immediate Release (IR) formulation (in fasted conditions) or as Modified Release (MR) formulation (in fasted and fed conditions)
| Arm | Type | Description |
|---|---|---|
| GLPG3312 SAD IR (Part 1) | EXPERIMENTAL | Single doses of GLPG3312 IR |
| Placebo SAD IR (Part 1) | PLACEBO_COMPARATOR | Single doses of Placebo IR |
| GLPG3312 SAD MR (Part 2) | EXPERIMENTAL | Single doses of GLPG3312 MR |
| Placebo SAD MR (Part 2) | PLACEBO_COMPARATOR | Single doses of Placebo MR |
| GLPG3312 FE MR (Part 3) | EXPERIMENTAL | Single dose of GLPG3312 MR in fed and fasted state |
| GLPG3312 MAD MR (Part 4) | EXPERIMENTAL | Multiple doses of GLPG3312 MR |
| Placebo MAD MR (Part 4) | PLACEBO_COMPARATOR | Multiple doses of Placebo MR |
| GLPG3312 MAD MR optimized (Part 4) | EXPERIMENTAL | Multiple doses of GLPG3312 MR |
| Placebo MAD MR optimized (Part 4) | PLACEBO_COMPARATOR | Multiple doses of Placebo MR |
| Name | Type | Description |
|---|---|---|
| GLPG3312 IR | DRUG | GLPG3312 IR tablets, up to 4 single ascending oral doses (A, B, C, D). |
| Placebo | DRUG | Placebo tablets |
| GLPG3312 MR | DRUG | GLPG3312 MR film-coated tablets, up to 4 single ascending oral doses (H, I, J, K). |
| GLPG3312 FE MR | DRUG | GLPG3312 MR film-coated tablets, single oral dose (N) on 2 occasions, i.e. in fed state after a high-fat high-calorie breakfast, and in fasted state. |
Inclusion Criteria: * Male or female between 18 to 55 years of age (extremes included), on the date of signing the Informed Consent Form (ICF). Female should be of non-childbearing potential defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilater...