A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants

Eisai

Status and phase: Completed; Phase 1

Conditions: Dementias With Lewy Bodies

Treatments: Drug: E2027

Study type: Interventional

Funder types: Industry

Identifiers

NCT04023877

E2027-A001-005

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

E2027

Experimental group

Description:

Participants will receive approximately 130 microcurie (μCi) of \[14C\]E2027 as a single 50 milligram (mg) (free base), capsule, orally on Day 1.

Treatment:

Drug: E2027