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Also known as GLPG3312 IR, GLPG3312 MR, GLPG3312 FE MR, GLPG3312 FE
GLPG3312 · 1 trial · 1 indication
To evaluate the safety and tolerability of oral single and multiple ascending doses of GLPG3312, in adult, healthy, subjects, when given as Immediate Release (IR) formulation (in fasted conditions) or as Modified Release (MR) formulation (in fasted and fed conditions)
| Arm | Type | Description |
|---|---|---|
| GLPG3312 SAD IR (Part 1) | EXPERIMENTAL | Single doses of GLPG3312 IR |
| Placebo SAD IR (Part 1) | PLACEBO_COMPARATOR | Single doses of Placebo IR |
| GLPG3312 SAD MR (Part 2) | EXPERIMENTAL | Single doses of GLPG3312 MR |
| Placebo SAD MR (Part 2) | PLACEBO_COMPARATOR | Single doses of Placebo MR |
| GLPG3312 FE MR (Part 3) | EXPERIMENTAL | Single dose of GLPG3312 MR in fed and fasted state |
| GLPG3312 MAD MR (Part 4) | EXPERIMENTAL | Multiple doses of GLPG3312 MR |
| Placebo MAD MR (Part 4) | PLACEBO_COMPARATOR | Multiple doses of Placebo MR |
| GLPG3312 MAD MR optimized (Part 4) | EXPERIMENTAL | Multiple doses of GLPG3312 MR |
| Placebo MAD MR optimized (Part 4) | PLACEBO_COMPARATOR | Multiple doses of Placebo MR |
| Name | Type | Description |
|---|---|---|
| GLPG3312 IR | DRUG | GLPG3312 IR tablets, up to 4 single ascending oral doses (A, B, C, D). |
| Placebo | DRUG | Placebo tablets |
| GLPG3312 MR | DRUG | GLPG3312 MR film-coated tablets, up to 4 single ascending oral doses (H, I, J, K). |
| GLPG3312 FE MR | DRUG | GLPG3312 MR film-coated tablets, single oral dose (N) on 2 occasions, i.e. in fed state after a high-fat high-calorie breakfast, and in fasted state. |
Inclusion Criteria: * Male or female between 18 to 55 years of age (extremes included), on the date of signing the Informed Consent Form (ICF). Female should be of non-childbearing potential defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilater...
GLPG3312 is an investigational small molecule drug being developed by Lakefront Biotherapeutics for the treatment of inflammatory diseases. It has completed a Phase 1 clinical trial in healthy volunteers. GLPG3312 is not approved and remains in clinical development.
GLPG3312 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company sponsored a Phase 1 study of the drug in the Netherlands. No other developer is associated with GLPG3312.
GLPG3312 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.
GLPG3312 has been studied in one completed Phase 1 trial, NCT03800472, titled a study investigating the safety, absorption and elimination of GLPG3312 in the treatment of inflammatory diseases. The trial enrolled 95 healthy volunteers in the Netherlands and was randomized, double blind, and placebo controlled.
Yes. GLPG3312 IR, GLPG3312 MR, GLPG3312 FE MR, and GLPG3312 FE are alternative names for GLPG3312. These designations refer to the same investigational small molecule developed by Lakefront Biotherapeutics, and searches using any of these names refer to the same drug asset.