Healthy Volunteers
Conditions
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.
Interventions
DRUG[14C]-Fosgonimeton
Carbon-14 Radiolabeled Fosgonimeton
Sponsors
Labcorp Corporation of America Holdings, Inc
Alturas Analytics, Inc.
Athira Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass balance of total radioactivity from [14C]-Fosgonimeton | Samples collected pre-dose. | Total radioactivity recovery (fet1-t2) |
| Routes/rates of elimination of [14C]-Fosgonimeton | Samples collected pre-dose. | Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces). |
| Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001 | 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 | Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. | Tmax will be determined from plasma samples |
| Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001 | Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. | AUC will be determined from plasma samples. |
| Half-life (t1/2) of ATH-1017/ATH-1001 | Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. | t1/2 will be determined from plasma samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Quantification of ATH-1017 major metabolites in plasma and excreta. |
| 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 | Identification of ATH-1017 major metabolites in plasma (\>10% relative total drug-related exposure) and excreta (\>10% of excreted 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 | Incidence and severity of adverse events |
Countries
United States
Outcome results
None listed