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Also known as GLPG2451 multiple dose, GLPG2451 single dose, GLPG2451 dose regimen B
GLPG2451 · 1 trial · 1 indication
To assess safety and tolerability of doses of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
To characterize the pharmacokinetics (PK) of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
To assess changes in sweat chloride concentration after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
To assess changes in percent predicted FEV1 after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
| Arm | Type | Description |
|---|---|---|
| Cohort A - F508del homozygous | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods.( Study Part I) |
| Cohort B - F508del heterozygous/potentiator nonresponsive | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods. (study Part II) |
| Cohort C - F508del homozygous | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods. (Study Part II) |
| Name | Type | Description |
|---|---|---|
| GLPG2451 dose regimen A | DRUG | GLPG2451 oral suspension, daily. |
| GLPG2451 dose regimen B | DRUG | GLPG2451 oral suspension, daily. |
| GLPG2222 | DRUG | GLPG2222 tablet for oral use, daily. |
| GLPG2737 | DRUG | GLPG2737 capsules for oral use, daily. |
Inclusion Criteria: * Female or male subject ≥18 years of age, on the day of signing the Informed Consent Form (ICF) * Confirmed clinical diagnosis of cystic fibrosis (CF) (documented in the subject's medical record). * Eligible cystic fibrosis transmembrane conductance regulator (CFTR) genotype at...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-272, Tezacaftor |
| 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 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
GLPG2451 is an investigational small molecule developed for cystic fibrosis, a respiratory disease. It was studied in a Phase 1 trial as part of a combination regimen with GLPG2222, with or without GLPG2737, in patients with cystic fibrosis. The trial has been completed, and the drug remains in clinical development.
GLPG2451 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company sponsored the Phase 1 study of the drug in cystic fibrosis.
GLPG2451 is in Phase 1 clinical development. It has completed one Phase 1 trial in patients with cystic fibrosis. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
GLPG2451 has been studied in one completed Phase 1 trial, NCT03540524, titled a study looking at the safety, tolerability and efficacy of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 in patients with cystic fibrosis. The trial enrolled 10 patients across Belgium, Bulgaria, Germany, Greece, Netherlands, Serbia, Sweden, and the United Kingdom.
Yes, GLPG2451 multiple dose, GLPG2451 single dose, GLPG2451 dose regimen A, and GLPG2451 dose regimen B are alternative names or dose regimens used for the same investigational drug, GLPG2451. These terms refer to different dosing schedules evaluated in its clinical development for cystic fibrosis.