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

NCT05511558 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ATH-1017-0102
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Dosing Group

EXPERIMENTAL

All 8 subjects will receive a single dose of study drug

Drug: [14C]-Fosgonimeton

Interventions

[14C]-Fosgonimeton DRUG

Carbon-14 Radiolabeled Fosgonimeton

Also known as: [14C]-ATH-1017

Dosing Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Athira Pharma: lead
• Labcorp Corporation of America Holdings, Inc: collaborator
• Alturas Analytics, Inc.: collaborator

Study Sites (1)

Labcorp Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 23, 2022
• Study Start: July 13, 2022
• Primary Completion: October 18, 2022
• Study Completion: October 26, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

US (1)