- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023877
A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants
December 2, 2019 updated by: Eisai Inc.
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Subjects
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53704
- Covance Clinical Research Unit Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: E2027
Participants will receive approximately 130 microcurie (μCi) of [14C]E2027 as a single 50 milligram (mg) (free base), capsule, orally on Day 1.
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E2027 oral capsule.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue)
Time Frame: Up to 56 days
|
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.
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Up to 56 days
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Maximum Concentration (Cmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time Frame: Pre-dose up to Day 56 post-dose
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Pre-dose up to Day 56 post-dose
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Time to Reach Maximum (Peak) Concentration (Tmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time Frame: Pre-dose up to Day 56 post-dose
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Pre-dose up to Day 56 post-dose
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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
Time Frame: Pre-dose up to Day 56 post-dose
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Pre-dose up to Day 56 post-dose
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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
Time Frame: Pre-dose up to Day 56 post-dose
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Pre-dose up to Day 56 post-dose
|
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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
Time Frame: Pre-dose up to Day 56 post-dose
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Pre-dose up to Day 56 post-dose
|
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Terminal Elimination Half-life (t1/2) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices
Time Frame: Pre-dose up to Day 56 post-dose
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Pre-dose up to Day 56 post-dose
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Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices
Time Frame: Pre-dose up to Day 56 post-dose
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Pre-dose up to Day 56 post-dose
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Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices
Time Frame: Pre-dose up to Day 28 post-dose
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Pre-dose up to Day 28 post-dose
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Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices
Time Frame: Pre-dose up to Day 28 post-dose
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Pre-dose up to Day 28 post-dose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 56 days post-dose
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Up to 56 days post-dose
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Number of Participants With Clinically Significant Abnormal Laboratory Values
Time Frame: Up to 56 days post-dose
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Up to 56 days post-dose
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Number of Participants With Clinically Significant Abnormal Vital Sign Values
Time Frame: Up to 56 days post-dose
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Up to 56 days post-dose
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Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Time Frame: Up to 56 days post-dose
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Up to 56 days post-dose
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Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time Frame: Baseline, Up to 56 days post-dose
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Baseline, Up to 56 days post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2019
Primary Completion (Actual)
October 11, 2019
Study Completion (Actual)
October 11, 2019
Study Registration Dates
First Submitted
July 16, 2019
First Submitted That Met QC Criteria
July 16, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
December 3, 2019
Last Update Submitted That Met QC Criteria
December 2, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2027-A001-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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