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

Completed · Phase 1

Conditions studied: Dementias With Lewy Bodies

In brief

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.

Key facts

Study ID

NCT04023877

Run by

Eisai Inc.

People needed

8

Starts

2019-07-18

Expected to finish

2019-10-11

Last updated by the study team

2019-12-03

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Participants must meet all of the following criteria to be included in this study:
• Body Mass Index (BMI) of 18 to 30 kilogram per square meter (kg/m\^2) at Screening

You may not qualify if…

• Participants who meet any of the following criteria will be excluded from this study:
• Have participated in a [14C]-research study within the 6 months prior to Day -1
• Exposure to clinically significant radiation (greater than [>] 100 millisieverts) within 12 months prior to Day -1
• Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection that required medical treatment within 4 weeks before dosing
• 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
• 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
• A prolonged QT/QTc interval (QTcF > 450 msec) as demonstrated by ECGs at Screening or Baseline
• Systolic blood pressure > 130 millimetres of mercury (mmHg) or diastolic blood pressure > 85 mmHg at Screening or Baseline
• Heart rate less than (<) 45 beats per minute (beats/min) or >100 beats/min at Screening or Baseline
• Known history of clinically significant drug allergy at Screening or Baseline
• Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
• Known to be human immunodeficiency virus (HIV) positive at Screening
• Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
• 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
• Use of tobacco or nicotine-containing products within 4 weeks before dosing
• 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
• Engagement in strenuous exercise within 2 weeks before dosing (example, marathon runners, weight lifters)
• Intake of caffeinated beverages or caffeinated food within 72 hours before dosing
• 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
• 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
• Use of any prescription drugs within 4 weeks before dosing
• Use of illegal recreational drugs
• Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing

Where it is running

• Covance Clinical Research Unit Inc. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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