Status:
COMPLETED
A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants
Lead Sponsor:
Eisai Inc.
Conditions:
Dementias With Lewy Bodies
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04023877
Start Date
July 18 2019
End Date
October 11 2019
Last Update
December 3 2019
Active Locations (1)
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1
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704