Clinical trial NCT05511558: A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Athira Pharma
Sponsor class: INDUSTRY
Collaborators: name: Labcorp Corporation of America Holdings, Inc
name: Alturas Analytics, Inc.
First posted: 2022-08-23
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mass balance of total radioactivity from [14C]-Fosgonimeton
timeFrame: Samples collected pre-dose.
measure: Mass balance of total radioactivity from [14C]-Fosgonimeton
timeFrame: Samples collected up to 9 days post-dose.
measure: Routes/rates of elimination of [14C]-Fosgonimeton
timeFrame: Samples collected pre-dose.
measure: Routes/rates of elimination of [14C]-Fosgonimeton
timeFrame: Samples collected up to 9 days post-dose.
measure: Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001
timeFrame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
measure: Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001
timeFrame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
measure: Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001
timeFrame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
measure: Half-life (t1/2) of ATH-1017/ATH-1001
timeFrame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Secondary outcomes:
measure: Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration
timeFrame: Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
measure: The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration
timeFrame: Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose
measure: Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects
timeFrame: Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorp Clinical Research Unit
state: Wisconsin
Study officials:
References: