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GLPG0492 · 3 trials · 1 indication
Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability
During a 5-hour infusion of phenylalanine two muscle biopsies will be taken; this procedure is performed before and after one week of treatment with GLPG0492, to determine the effect of the compound.
| Arm | Type | Description |
|---|---|---|
| GLPG0492 oral solution | EXPERIMENTAL | Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day |
| Placebo | PLACEBO_COMPARATOR | Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2). |
| Placebo oral solution | PLACEBO_COMPARATOR | Once daily dosing for 14 days |
| 1 | EXPERIMENTAL | single ascending doses |
| 2 | PLACEBO_COMPARATOR | single dose placebo |
| 3 | EXPERIMENTAL | single dose, oral solution, 50 mg |
| 4 | EXPERIMENTAL | single dose, capsules (fasting) |
| 5 | EXPERIMENTAL | single dose, capsules (fed) |
| Name | Type | Description |
|---|---|---|
| GLPG0492 | DRUG | Oral solution |
| Placebo | DRUG | Placebo oral solution |
Inclusion Criteria: * Healthy male, age 18-50 years (for part 1), and postmenopausal subjects age 35-65 years (for part 2) * Body mass index (BMI) between 18-30 kg/m², inclusive. * For men: normal values of testosterone (175-781 ng/dL) and LH (1.24-8.62 U/L). * Women must be postmenopausal for at l...
GLPG0492 is an investigational small molecule developed by Lakefront Biotherapeutics. It is an androgen receptor (AR) modulator that has been studied in Phase 1 clinical trials involving healthy volunteers. The specific therapeutic indications for GLPG0492 have not been publicly disclosed.
GLPG0492 targets the androgen receptor (AR). It is classified as an AR modulator, meaning it is designed to interact with and modulate the activity of the androgen receptor. This mechanism was evaluated in early-stage clinical studies conducted in healthy male volunteers.
GLPG0492 is being developed by Lakefront Biotherapeutics, which trades under the ticker symbol LKFT. The company is responsible for the clinical development program, which to date has consisted of Phase 1 studies conducted in Belgium and Germany.
GLPG0492 is in Phase 1 clinical development. All three of its completed trials were Phase 1 studies, and no later-stage trials have been initiated. The drug remains investigational and has not been approved by the FDA for any indication.
GLPG0492 has been evaluated in three completed Phase 1 trials: NCT01130818, a first-in-human single ascending dose study; NCT01397370, a multiple ascending dose study in healthy subjects; and NCT01538420, a pharmacodynamics study. Together these trials enrolled 78 participants.
GLPG0492 is the compound's primary identifier and is also referenced by its ChEMBL database ID, CHEMBL2178100. No other alternative names for this investigational androgen receptor modulator have been publicly established.