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GLPG4716 · 2 trials · 1 indication
To determine the effect of GLPG4716 on the pharmacokinetics (PK) of MDZ
To determine the effect of GLPG4716 on the PK of MDZ
To determine the effect of GLPG4716 on the PK of pirfenidone
To determine the effect of GLPG4716 on the PK of pirfenidone
To determine the effect of GLPG4716 on the PK of nintedanib.
To determine the effect of GLPG4716 on the PK of nintedanib.
| Arm | Type | Description |
|---|---|---|
| GLPG4716 and Midazolam | EXPERIMENTAL | - |
| GLPG4716 and pirfenidone | EXPERIMENTAL | - |
| GLPG4716 and nintedanib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GLPG4716 | DRUG | From Day 3 to Day 14, participants will receive GLPG4716 tablets once daily in fasted state. On Day 8 GLPG4716 will be administered in fed state. |
| Midazolam | DRUG | On Days 1, 3 and 13, participants will receive a single oral dose of MDZ as an oral solution in fasted state. |
| Pirfenidone | DRUG | On Days 1 and 13, participants will receive an oral dose of pirfenidone. |
| Nintedanib | DRUG | On Days 1 and 13, participants will receive an oral dose of nintedanib. |
Inclusion Criteria: * Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form. Female subjects should be of non-childbearing potential. * A body mass index between 18.0 and 30.0 kg/m2, inclusive. * Judged to be in good health by the invest...
GLPG4716 is an investigational small molecule drug developed by Lakefront Biotherapeutics. It is in Phase 1 clinical development, and its intended therapeutic indication has not been disclosed. The program has been studied in healthy adult volunteers rather than in patients with a specific disease.
GLPG4716 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company is the sponsor of the clinical program for this small molecule asset.
GLPG4716 is in Phase 1 clinical development. It is an investigational drug and is not approved for any indication. Two Phase 1 trials have been completed, and no trials are currently active.
GLPG4716 has been evaluated in two completed Phase 1 trials. NCT05030857 was a drug-drug interaction and food-effect study with midazolam in 19 healthy subjects in Canada. NCT04971746 was a drug-drug interaction study with nintedanib and pirfenidone in 58 healthy subjects in Germany.
Across the two completed Phase 1 trials, 77 healthy volunteers were enrolled. NCT05030857 enrolled 19 participants, and NCT04971746 enrolled 58 participants. Both studies enrolled adults aged 18 years and older and included both sexes.
The therapeutic indication for GLPG4716 has not been disclosed. Both completed Phase 1 trials were conducted in healthy volunteers, one assessing drug-drug interactions and food effects with midazolam, and the other assessing drug-drug interactions with nintedanib and pirfenidone.