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Also known as GLPG1837 as, GLPG1837 single ascending doses, GLPG1837 dose 1
GLPG1837 · 5 trials · 2 indications
To evaluate the safety and tolerability of GLPG1837 in terms of adverse events at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal laboratory parameters at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal vital signs as measured by temperature, blood pressure, heart rate and respiratory rate, at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormalities during physical examination at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal electrocardiogram at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal vital signs at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal physical examination at every visit
To characterize and compare the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the area under the plasma concentration versus time curve of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the apparent terminal half-life of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize and compare the metabolite over GLPG1837 ratios in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects
To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects
To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
| Arm | Type | Description |
|---|---|---|
| GLPG1837 dose 1, GLPG1837 dose 2, GLPG1837 dose 3 | EXPERIMENTAL | GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks |
| GLPG1837 dose 1 and GLPG1837 dose 2 | EXPERIMENTAL | GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks |
| GLPG1837 as oral suspension fasted | EXPERIMENTAL | Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast |
| GLPG1837 as oral tablet fasted | EXPERIMENTAL | Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast |
| GLPG1837 as oral tablet fed | EXPERIMENTAL | Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast |
| Midazolam and 500 mg GLPG1837 | EXPERIMENTAL | Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11. |
| Midazolam and 1000 mg GLPG1837 | EXPERIMENTAL | Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12. |
| GLPG1837 single dose | EXPERIMENTAL | Single oral dose of GLPG1837 suspension - ascending doses |
| Placebo single dose | PLACEBO_COMPARATOR | Single oral dose of placebo suspension |
| GLPG1837 muliple doses | EXPERIMENTAL | Multiple oral doses of GLPG1837 suspension - ascending doses |
| Placebo multiple doses | PLACEBO_COMPARATOR | Multiple oral doses of placebo suspension |
| Name | Type | Description |
|---|---|---|
| GLPG1837 dose 1 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week |
| GLPG1837 dose 2 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week |
| GLPG1837 dose 3 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks |
| 500 mg GLPG1837 as oral suspension | DRUG | A single dose of 500 mg GLPG1837 administered as oral suspension |
| 500 mg GLPG1837 as oral tablet | DRUG | A single dose of 500 mg GLPG1837 administered as oral tablet |
| GLPG1837 500 mg | DRUG | Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12. |
| Midazolam | DRUG | Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12). |
| GLPG1837 1000 mg | DRUG | Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12. |
| GLPG1837 single ascending doses | DRUG | Single dose, oral suspension |
| Placebo single dose | DRUG | Single dose, oral suspension matching placebo |
| GLPG1837 multiple ascending doses | DRUG | Multiple doses, daily for 14 days, oral suspension |
| Placebo multiple doses | DRUG | Multiple doses, daily for 14 days, oral suspension, matching placebo |
Inclusion Criteria: * Male or female subjects ≥ 18 years of age, with a confirmed diagnosis of cystic fibrosis * Subjects with gating G551D CFTR mutation on at least one allele in the CFTR gene * Subjects currently receiving treatment with ivacaftor on a stable regimen or not on a treatment regimen...
Top 5 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-522, VX-272 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |