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A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Subjects
Lead sponsor
Asset
Irsenontrine
Listed sites
1
Recruiting sites
-
Enrollment
8
actual
Study population
Lewy body dementia
Key I/E criteria
•Age 18-55•Male
Primary endpoints
•Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices•Cmax of Radiolabeled [14C]E2027, Non-Radiolabeled E2027•Reach Maximum (Peak) Concentration (Tmax) of Radiolabeled [14C]E2027
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Participants must meet all of the following criteria to be included in this study:
1. Body Mass Index (BMI) of 18 to 30 kilogram per square meter (kg/m^2) at Screening
Exclusion criteria
Participants who meet any of the following criteria will be excluded from this study:
1. Have participated in a [14C]-research study within the 6 months prior to Day -1
2. Exposure to clinically significant radiation (greater than [>] 100 millisieverts) within 12 months prior to Day -1
3. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection that required medical treatment within 4 weeks before dosing
4. Any history of abdominal surgery that may affect pharmacokinetic profiles of study drug (example, hepatectomy, nephrectomy, digestive organ resection but not cholecystectomy nor appendectomy) at Screening or Baseline
5. Any other clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding (including PR > 210 millisecond [msec], QRS > 110 msec), or laboratory test results that required medical treatment at Screening or Baseline
6. A prolonged QT/QTc interval (QTcF > 450 msec) as demonstrated by ECGs at Screening or Baseline
7. Systolic blood pressure > 130 millimetres of mercury (mmHg) or diastolic blood pressure > 85 mmHg at Screening or Baseline
8. Heart rate less than (<) 45 beats per minute (beats/min) or >100 beats/min at Screening or Baseline
9. Known history of clinically significant drug allergy at Screening or Baseline
10. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
11. Known to be human immunodeficiency virus (HIV) positive at Screening
12. Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
13. History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug or alcohol test at Screening or Baseline
14. Use of tobacco or nicotine-containing products within 4 weeks before dosing
15. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) preceding informed consent
16. Engagement in strenuous exercise within 2 weeks before dosing (example, marathon runners, weight lifters)
17. Intake of caffeinated beverages or caffeinated food within 72 hours before dosing
18. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (example, alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [example, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard], and charbroiled meats) within 1 week before dosing
19. Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing Intake of over-the-counter (OTC) medications within 14 days (or 5 half-lives, whichever is longer) before dosing unless the investigator and sponsor medical monitor consider that they do not compromise participant safety or study assessments
20. Use of any prescription drugs within 4 weeks before dosing
21. Use of illegal recreational drugs
22. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing
Endpoints (15)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
10 endpointsMaximum Concentration (Cmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame:Pre-dose up to Day 56 post-dose
concentration, descriptive
Time to Reach Maximum (Peak) Concentration (Tmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame:Pre-dose up to Day 56 post-dose
time to event, event
Area Under the Concentration-Time Curve From Time Zero to 24 hours (AUC(0-24h)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame:Pre-dose up to Day 56 post-dose
concentration, descriptive
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC(0-t)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame:Pre-dose up to Day 56 post-dose
concentration, descriptive
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC(0-inf)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame:Pre-dose up to Day 56 post-dose
concentration, descriptive
Terminal Elimination Half-life (t1/2) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time frame:Pre-dose up to Day 56 post-dose
concentration, descriptive
Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices
Time frame:Pre-dose up to Day 28 post-dose
concentration, descriptive
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame:Up to 56 days post-dose
event count, event
Number of Participants With Clinically Significant Abnormal Vital Sign Values
Time frame:Up to 56 days post-dose
event count, event
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Time frame:Up to 56 days post-dose
event count, event
Other (unclassified)
5 endpointsCumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue)
Time frame:Up to 56 days
descriptive
Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices
Time frame:Pre-dose up to Day 56 post-dose
descriptive
Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices
Time frame:Pre-dose up to Day 28 post-dose
descriptive
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame:Up to 56 days post-dose
event count, event
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame:Baseline, Up to 56 days post-dose
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.