Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GLPG3067 single dose
GLPG3067 · 2 trials · 2 indications
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
To assess safety and tolerability of single ascending doses, multiple ascending doses of GLPG3067 alone, or in combination with GLPG2222, or in combination with GLPG2222 and GLPG2737 versus placebo in healthy subjects
| Arm | Type | Description |
|---|---|---|
| GLPG3067 single dose. | EXPERIMENTAL | Single Dose of GLPG3067 film coated tablets. |
| GLPG3067 single dose | EXPERIMENTAL | Single dose of GLPG3067 oral suspension at up to 6 dose levels in ascending order. |
| Placebo single dose | PLACEBO_COMPARATOR | Single dose of Placebo oral suspension. |
| GLPG3067 oral suspension fed 1 | EXPERIMENTAL | Single dose 1 of GLPG3067 oral suspension after a standardized breakfast. |
| GLPG3067 oral tablet fed 1 | EXPERIMENTAL | Single dose 1 of GLPG3067 oral tablet after a standardized breakfast. |
| GLPG3067 oral tablet fasted 1 | EXPERIMENTAL | Single dose 1 of GLPG3067 oral tablet after an overnight fast. |
| GLPG3067 oral tablet fed 2 | EXPERIMENTAL | Single dose 2 of GLPG3067 oral tablet after a standardized breakfast. |
| GLPG3067 oral tablet fed 2 high-fat high-calorie | EXPERIMENTAL | Single dose 2 of GLPG3067 oral tablet after a high-fat high-calorie breakfast |
| GLPG3067 multiple dose | EXPERIMENTAL | Multiple doses of GLPG3067 oral suspension at up to 5 dose levels in ascending order. |
| Placebo multiple dose | PLACEBO_COMPARATOR | Multiple doses of Placebo oral suspension. |
| GLPG3067/GLPG2222 multiple dose | EXPERIMENTAL | Multiple doses of GLPG3067 oral suspension combined with GLPG2222 oral tablet up to 2 dose levels in ascending order. |
| GLPG3067/GLPG2222 Placebo multiple dose | PLACEBO_COMPARATOR | Multiple doses of GLPG3067 matching placebo oral suspension combined with GLPG2222 matching placebo oral tablet. |
| GLPG3067/GLPG2222/GLPG2737 multiple dose | EXPERIMENTAL | Multiple doses of GLPG3067 oral tablet combined with GLPG2222 oral tablet and GLPG2737 oral capsule at up to 2 dose levels in ascending order. |
| GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose | PLACEBO_COMPARATOR | Multiple doses of GLPG3067 matching placebo oral tablet combined with GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule. |
| Name | Type | Description |
|---|---|---|
| GLPG3067 single dose | DRUG | GLPG3067 film coated tablets provided at Day 1. |
| Placebo single dose | DRUG | Placebo, oral suspension, daily |
| GLPG3067 multiple dose | DRUG | GLPG3067 oral suspension, multiple ascending doses, daily for 14 days |
| Placebo multiple dose | DRUG | Placebo, oral suspension, daily for 14 days |
| GLPG3067 oral suspension | DRUG | GLPG3067 oral suspension, single dose, daily |
| GLPG3067 oral tablet | DRUG | GLPG3067 oral tablet, single dose, daily |
| GLPG3067/GLPG2222 multiple dose | DRUG | GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days |
| GLPG3067/GLPG2222 Placebo multiple dose | DRUG | GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days |
| GLPG3067/GLPG2222/GLPG2737 multiple dose | DRUG | GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days |
| GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose | DRUG | GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days |
Inclusion Criteria: * Male subject ≥18 years of age on the day of signing the ICF. * A confirmed clinical diagnosis of CF. * Exocrine pancreatic insufficiency (documented in the subject's medical record). * Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to stu...
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 |