This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of \[14C\]-Fosgonimeton
This is a Phase 1, open-label, nonrandomized, single-dose study, designed to evaluate the absorption, metabolism, and excretion of \[14C\]-Fosgonimeton. Healthy male subjects will receive a single subcutaneous dose of \[14C\]-Fosgonimeton.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Carbon-14 Radiolabeled Fosgonimeton
Labcorp Clinical Research Unit
Madison, Wisconsin, United States
Mass balance of total radioactivity from [14C]-Fosgonimeton
Total radioactivity recovery (fet1-t2)
Time frame: Samples collected pre-dose.
Mass balance of total radioactivity from [14C]-Fosgonimeton
Total radioactivity recovery (fet1-t2)
Time frame: Samples collected up to 9 days post-dose.
Routes/rates of elimination of [14C]-Fosgonimeton
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Time frame: Samples collected pre-dose.
Routes/rates of elimination of [14C]-Fosgonimeton
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Time frame: Samples collected up to 9 days post-dose.
Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001
Cmax will be determined from plasma samples.
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001
Tmax will be determined from plasma samples
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001
AUC will be determined from plasma samples.
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Half-life (t1/2) of ATH-1017/ATH-1001
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t1/2 will be determined from plasma samples.
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration
Quantification of ATH-1017 major metabolites in plasma and excreta.
Time frame: Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration
Identification of ATH-1017 major metabolites in plasma (\>10% relative total drug-related exposure) and excreta (\>10% of excreted dose)
Time frame: Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects
Incidence and severity of adverse events
Time frame: Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose