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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]-Fosgonimeton

• Registration Number: NCT05511558
• Lead Sponsor: Athira Pharma

Brief Summary

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

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 Timeline

• Study Start: 2022-07-13
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-23
• Primary Completion: 2022-10-18
• Study Completion: 2022-10-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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. History of a minimum of 1 bowel movement per day.

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Exclusion Criteria

1. Significant history or clinical manifestation of any relevant, significant medical disorder, as determined by the investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. Positive hepatitis panel and/or positive human immunodeficiency virus test.
4. Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
5. Use or intend to use any nonprescription medications within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
6. 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.
7. Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
8. Poor peripheral venous access.
9. Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial x-ray, computed tomography scan, barium meal)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dosing Group	[14C]-Fosgonimeton	All 8 subjects will receive a single dose of study drug

Primary Outcome Measures

Name	Time	Method
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).
Mass balance of total radioactivity from [14C]-Fosgonimeton	Samples collected up to 9 days post-dose.	Total radioactivity recovery (fet1-t2)
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.
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
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

Name	Time	Method
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)
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.
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

Trial Locations

Locations (1)

Labcorp Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States