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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Labcorp Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: [14C]-ATH-1017

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Athira Pharma
• Collaborators: Alturas Analytics, Inc.; Labcorp Drug Development Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): October 18, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ATH-1017-0102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No