Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fosgonimeton · 1 trial · 1 indication
Total radioactivity recovery (fet1-t2)
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Cmax will be determined from plasma samples.
Tmax will be determined from plasma samples
AUC will be determined from plasma samples.
t1/2 will be determined from plasma samples.
| Arm | Type | Description |
|---|---|---|
| Dosing Group | EXPERIMENTAL | All 8 subjects will receive a single dose of study drug |
| Name | Type | Description |
|---|---|---|
| [14C]-Fosgonimeton | DRUG | Carbon-14 Radiolabeled Fosgonimeton |
Inclusion Criteria: 1. Males, of any race, between 18 and 60 years of age, inclusive. 2. Body mass index between 18.0 and 32.0 kg/m2, inclusive. 3. In good health, determined by the investigator's discretion 4. Subjects and their partners will agree to use contraception during their participation 5...
Fosgonimeton is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated for its absorption, metabolism, and excretion in the human body. Fosgonimeton is not approved for any medical condition and remains in early-stage clinical research.
Fosgonimeton is being developed by LeonaBio, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers. LeonaBio is responsible for the research and development of Fosgonimeton as an investigational small molecule therapy.
Fosgonimeton is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers. The drug is not yet approved by regulatory authorities and is still in the early stages of clinical research. Its safety and pharmacological properties are being evaluated in this initial phase of testing.
Fosgonimeton has one completed Phase 1 clinical trial registered as NCT05511558. This study examined the absorption, metabolism, and excretion of [14C]-Fosgonimeton (ATH-1017) in healthy male volunteers in the United States. The trial enrolled 8 participants aged 18 years and older.
Yes, Fosgonimeton is also known as ATH-1017. The clinical trial NCT05511558 refers to the drug as [14C]-Fosgonimeton (ATH-1017), confirming that both names refer to the same investigational compound. This alternative name may be used in research literature and clinical trial documentation.