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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03214614 | A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Male Subjects | PHASE1 | COMPLETED | 39 | — | — | Nov 14, 2016 | Aug 25, 2017 | Sep 13, 2017 | 1 | Belgium |
| NCT02788721 | A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Female Subjects | PHASE1 | COMPLETED | 31 | — | — | Apr 14, 2016 | Apr 27, 2017 | Jul 12, 2017 | 1 | Belgium |
To assess safety and tolerability of multiple ascending doses and combination of GLPG2451 with GLPG2222 versus placebo in healthy subjects
| Arm | Type | Description |
|---|---|---|
| GLPG2451 multiple dose | EXPERIMENTAL | Multiple doses of GLPG2451 oral suspension at up to 3 dose levels in ascending order |
| Placebo multiple dose | PLACEBO_COMPARATOR | Multiple doses of Placebo oral suspension |
| GLPG2451/GLPG2222 | EXPERIMENTAL | Multiple doses of GLPG2451 oral suspension combined GLPG2222 oral suspension at up to 2 dose levels |
| Combined Placebo multiple dose | PLACEBO_COMPARATOR | Multiple doses of Combined Placebo oral suspension |
| GLPG2451 single dose | EXPERIMENTAL | Single dose of GLPG2451 oral suspension at up to 4 dose levels in ascending order |
| Placebo single dose | PLACEBO_COMPARATOR | Single dose of Placebo oral suspension |
| Name | Type | Description |
|---|---|---|
| GLPG2451 multiple dose | DRUG | GLPG2451 oral suspension, multiple ascending doses, daily for 14 days |
| Placebo multiple dose | DRUG | Placebo, oral suspension, daily for 14 days |
| GLPG2451/GLPG2222 multiple dose | DRUG | GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days |
| Combined Placebo multiple dose | DRUG | Combined Placebo, oral suspension, daily for 14 days |
| GLPG2451 single dose | DRUG | GLPG2451 oral suspension, single ascending doses, daily |
| Placebo | DRUG | Placebo, oral suspension, daily |
Inclusion Criteria: * Male between 18 and 50 years of age inclusive, on the date of signing the Informed Consent Form (ICF). * A body mass index (BMI) between 18-30 kg/m2, inclusive. * Judged by the investigator to be in good health based upon the results of a medical history, physical examination,...