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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05511558
• Other study ID #: ATH-1017-0102
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2022
• Est. completion date: October 26, 2022

Study information

• Verified date: December 2022
• Source: Athira Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 26, 2022
• Est. primary completion date: October 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-Fosgonimeton
Carbon-14 Radiolabeled Fosgonimeton

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Athira Pharma	Alturas Analytics, Inc., Labcorp Drug Development Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance of total radioactivity from [14C]-Fosgonimeton	Total radioactivity recovery (fet1-t2)	Samples collected pre-dose.
Primary	Mass balance of total radioactivity from [14C]-Fosgonimeton	Total radioactivity recovery (fet1-t2)	Samples collected up to 9 days post-dose.
Primary	Routes/rates of elimination of [14C]-Fosgonimeton	Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).	Samples collected pre-dose.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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