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[14C]-Fosgonimeton for Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Athira Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Awards & highlights
Study Summary
This trial is testing a new drug to see how it's absorbed, metabolized, and excreted by humans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001
Half-life (t1/2) of ATH-1017/ATH-1001
Mass balance of total radioactivity from [14C]-Fosgonimeton
+3 moreSecondary outcome measures
Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects
Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration
The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dosing GroupExperimental Treatment1 Intervention
All 8 subjects will receive a single dose of study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[14C]-Fosgonimeton
2022
Completed Phase 1
~10
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Labcorp Drug Development, Inc.Industry Sponsor
10 Previous Clinical Trials
529 Total Patients Enrolled
Alturas Analytics, Inc.UNKNOWN
1 Previous Clinical Trials
32 Total Patients Enrolled
Athira PharmaLead Sponsor
6 Previous Clinical Trials
1,233 Total Patients Enrolled
Frequently Asked Questions
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