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
Overview
- Phase
- Phase 1
- Intervention
- [14C]-Fosgonimeton
- Conditions
- Healthy Volunteers
- Sponsor
- Athira Pharma
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Mass balance of total radioactivity from [14C]-Fosgonimeton
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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)
Arms & Interventions
Dosing Group
All 8 subjects will receive a single dose of study drug
Intervention: [14C]-Fosgonimeton
Outcomes
Primary Outcomes
Mass balance of total radioactivity from [14C]-Fosgonimeton
Time Frame: Samples collected up to 9 days post-dose.
Total radioactivity recovery (fet1-t2)
Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001
Time Frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
AUC will be determined from plasma samples.
Routes/rates of elimination of [14C]-Fosgonimeton
Time Frame: Samples collected up to 9 days post-dose.
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001
Time Frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Cmax will be determined from plasma samples.
Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001
Time Frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Tmax will be determined from plasma samples
Half-life (t1/2) of ATH-1017/ATH-1001
Time Frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
t1/2 will be determined from plasma samples.
Secondary Outcomes
- 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)