A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)

Study Overview
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Brief Summary
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This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of [14C]-Fosgonimeton

Detailed Description
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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.

Official Title
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A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017) Following a Single Subcutaneous Dose in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]-Fosgonimeton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, of any race, between 18 and 60 years of age, inclusive. Body mass index between 18.0 and 32.0 kg/m2, inclusive. In good health, determined by the investigator's discretion Subjects and their partners will agree to use contraception during their participation History of a minimum of 1 bowel movement per day. Exclusion Criteria: Significant history or clinical manifestation of any relevant, significant medical disorder, as determined by the investigator (or designee). History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). Positive hepatitis panel and/or positive human immunodeficiency virus test. Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee). Use or intend to use any nonprescription medications within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee). Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing. Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months Poor peripheral venous access. Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial x-ray, computed tomography scan, barium meal)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing Group<br>All 8 subjects will receive a single dose of study drug | Drug: [14C]-Fosgonimeton<br>* Carbon-14 Radiolabeled Fosgonimeton<br>* Other names: [14C]-ATH-1017;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance of total radioactivity from [14C]-Fosgonimeton | Total radioactivity recovery (fet1-t2) | Samples collected pre-dose. | 
| Mass balance of total radioactivity from [14C]-Fosgonimeton | Total radioactivity recovery (fet1-t2) | 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). | Samples collected pre-dose. | 
| Routes/rates of elimination of [14C]-Fosgonimeton | Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces). | 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. | 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 | 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. | Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. | 
| Half-life (t1/2) of ATH-1017/ATH-1001 | t1/2 will be determined from plasma samples. | Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration | Quantification of ATH-1017 major metabolites in plasma and excreta. | 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) | 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 | Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose |