A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)
Study Details
Study Description
Brief Summary
This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of [14C]-Fosgonimeton
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dosing Group All 8 subjects will receive a single dose of study drug |
Drug: [14C]-Fosgonimeton
Carbon-14 Radiolabeled Fosgonimeton
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mass balance of total radioactivity from [14C]-Fosgonimeton [Samples collected pre-dose.]
Total radioactivity recovery (fet1-t2)
- Mass balance of total radioactivity from [14C]-Fosgonimeton [Samples collected up to 9 days post-dose.]
Total radioactivity recovery (fet1-t2)
- Routes/rates of elimination of [14C]-Fosgonimeton [Samples collected pre-dose.]
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
- Routes/rates of elimination of [14C]-Fosgonimeton [Samples collected up to 9 days post-dose.]
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
- Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001 [Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.]
Cmax will be determined from plasma samples.
- Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001 [Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.]
Tmax will be determined from plasma samples
- Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001 [Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.]
AUC will be determined from plasma samples.
- Half-life (t1/2) of ATH-1017/ATH-1001 [Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.]
t1/2 will be determined from plasma samples.
Secondary Outcome Measures
- Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration [Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose]
Quantification of ATH-1017 major metabolites in plasma and excreta.
- The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration [Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose]
Identification of ATH-1017 major metabolites in plasma (>10% relative total drug-related exposure) and excreta (>10% of excreted dose)
- Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects [Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose]
Incidence and severity of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males, of any race, between 18 and 60 years of age, inclusive.
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Body mass index between 18.0 and 32.0 kg/m2, inclusive.
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In good health, determined by the investigator's discretion
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Subjects and their partners will agree to use contraception during their participation
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History of a minimum of 1 bowel movement per day.
Exclusion Criteria:
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Significant history or clinical manifestation of any relevant, significant medical disorder, as determined by the investigator (or designee).
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History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
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Positive hepatitis panel and/or positive human immunodeficiency virus test.
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Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
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Use or intend to use any nonprescription medications within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
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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.
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Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
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Poor peripheral venous access.
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Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial x-ray, computed tomography scan, barium meal)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Labcorp Clinical Research Unit | Madison | Wisconsin | United States | 53704 |
Sponsors and Collaborators
- Athira Pharma
- Labcorp Drug Development, Inc.
- Alturas Analytics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ATH-1017-0102