Dementias With Lewy Bodies Clinical Trial
Official title:
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Subjects
| Verified date | July 2019 |
| Source | Eisai Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of the study is to achieve mass balance recovery of [14C]-radiolabel in urine and feces and to identify and quantify the main elimination pathways of E2027.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | October 11, 2019 |
| Est. primary completion date | October 11, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Covance Clinical Research Unit Inc. | Madison | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Eisai Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue) | Blood, urine, feces and toilet tissue samples will be collected at specific time points and will be analyzed for the amount of radiolabeled [14C]E2027. | Up to 56 days | |
| Primary | Maximum Concentration (Cmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | ||
| Primary | Time to Reach Maximum (Peak) Concentration (Tmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | ||
| Primary | 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 | Pre-dose up to Day 56 post-dose | ||
| Primary | 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 | Pre-dose up to Day 56 post-dose | ||
| Primary | 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 | Pre-dose up to Day 56 post-dose | ||
| Primary | Terminal Elimination Half-life (t1/2) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices | Pre-dose up to Day 56 post-dose | ||
| Primary | Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices | Pre-dose up to Day 56 post-dose | ||
| Primary | Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices | Pre-dose up to Day 28 post-dose | ||
| Primary | Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices | Pre-dose up to Day 28 post-dose | ||
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 56 days post-dose | ||
| Secondary | Number of Participants With Clinically Significant Abnormal Laboratory Values | Up to 56 days post-dose | ||
| Secondary | Number of Participants With Clinically Significant Abnormal Vital Sign Values | Up to 56 days post-dose | ||
| Secondary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | Up to 56 days post-dose | ||
| Secondary | Number of Participants With Clinically Significant Abnormal Physical Examination Findings | Baseline, Up to 56 days post-dose |