Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GLPG4399 oral suspension
GLPG4399 · 1 trial · 1 indication
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG4399 in adult, healthy, male subjects.
| Arm | Type | Description |
|---|---|---|
| GLPG4399 SAD | EXPERIMENTAL | Single doses of GLPG4399 at up to 6 dose levels in ascending order |
| Placebo SAD | PLACEBO_COMPARATOR | Single doses of placebo |
| GLPG4399 MAD | EXPERIMENTAL | Multiple ascending doses of GLPG4399 |
| Placebo MAD | PLACEBO_COMPARATOR | Multiple doses of placebo |
| GLPG4399 FE-rBA | EXPERIMENTAL | Single dose of GLPG4399 in fed and fasted state |
| GLPG4399 FE | EXPERIMENTAL | Single dose of GLPG4399 in fed and fasted state |
| Name | Type | Description |
|---|---|---|
| GLPG4399 oral suspension | DRUG | GLPG4399 for oral administration |
| GLPG4399 capsules | DRUG | GLPG4399 for oral administration |
| Placebo | DRUG | Placebo oral suspension |
Inclusion Criteria: * Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). * A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. * Judged to be in good health by the investigator based upon the results of a medical history, phy...
GLPG4399 is an investigational small molecule drug developed by Lakefront Biotherapeutics. It is in Phase 1 clinical development and has been studied in healthy adult volunteers. GLPG4399 is also known as GLPG4399 oral suspension, which is the oral suspension formulation of the same compound.
GLPG4399 targets SIK3, a kinase enzyme. SIK3 belongs to the salt-inducible kinase family, and GLPG4399 is designed as a small molecule that acts on this kinase target. Targeting SIK3 places GLPG4399 in the kinase inhibitor class of therapeutic agents.
GLPG4399 is developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. Lakefront Biotherapeutics is the company responsible for the clinical development of GLPG4399 and its oral suspension formulation.
GLPG4399 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program has completed one trial, and no active trials are currently listed for GLPG4399.
GLPG4399 has been evaluated in one completed Phase 1 trial, NCT04653467, titled a study to evaluate how well single and multiple doses of GLPG4399 are tolerated in healthy, adult subjects. The trial enrolled 88 participants in Canada and was randomized, double-blind, and placebo-controlled.
Yes, GLPG4399 oral suspension is another name for GLPG4399. The oral suspension refers to the liquid formulation used in clinical testing of the same investigational small molecule developed by Lakefront Biotherapeutics.