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

NCT ID: NCT04023877

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-18
• Study Completion Date: 2019-10-11

Brief Summary

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.

Conditions

Dementias With Lewy Bodies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E2027

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

Group Type: EXPERIMENTAL

E2027

Intervention Type: DRUG

E2027 oral capsule.

Interventions

E2027

E2027 oral capsule.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

E2027-A001-005

Identifier Type: -

Identifier Source: org_study_id