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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01538420 | GLPG0492 Pharmacodynamics | PHASE1 | COMPLETED | 26 | — | — | Jan 1, 2012 | Apr 1, 2012 | Apr 19, 2012 | 1 | Belgium |
| NCT01397370 | Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects | PHASE1 | COMPLETED | 24 | — | — | Jul 1, 2011 | Dec 1, 2011 | Feb 20, 2012 | 1 | Germany |
| NCT01130818 | First-in-Human Single Ascending Dose of GLPG0492 | PHASE1 | COMPLETED | 28 | — | — | May 1, 2010 | Sep 1, 2010 | Mar 1, 2024 | 1 | Belgium |
Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability
During a 5-hour infusion of phenylalanine two muscle biopsies will be taken; this procedure is performed before and after one week of treatment with GLPG0492, to determine the effect of the compound.
| Arm | Type | Description |
|---|---|---|
| GLPG0492 oral solution | EXPERIMENTAL | Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day |
| Placebo | PLACEBO_COMPARATOR | Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2). |
| Placebo oral solution | PLACEBO_COMPARATOR | Once daily dosing for 14 days |
| 1 | EXPERIMENTAL | single ascending doses |
| 2 | PLACEBO_COMPARATOR | single dose placebo |
| 3 | EXPERIMENTAL | single dose, oral solution, 50 mg |
| 4 | EXPERIMENTAL | single dose, capsules (fasting) |
| 5 | EXPERIMENTAL | single dose, capsules (fed) |
| Name | Type | Description |
|---|---|---|
| GLPG0492 | DRUG | Oral solution |
| Placebo | DRUG | Placebo oral solution |
Inclusion Criteria: * Healthy male, age 18-50 years (for part 1), and postmenopausal subjects age 35-65 years (for part 2) * Body mass index (BMI) between 18-30 kg/m², inclusive. * For men: normal values of testosterone (175-781 ng/dL) and LH (1.24-8.62 U/L). * Women must be postmenopausal for at l...