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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2022-10-26

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dosing Group

All 8 subjects will receive a single dose of study drug

Group Type EXPERIMENTAL

[14C]-Fosgonimeton

Intervention Type DRUG

Carbon-14 Radiolabeled Fosgonimeton

Interventions

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[14C]-Fosgonimeton

Carbon-14 Radiolabeled Fosgonimeton

Intervention Type DRUG

Other Intervention Names

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[14C]-ATH-1017

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes