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

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ClinicalTrials.gov Identifier: NCT04023877
Recruitment Status : Active, not recruiting
First Posted : July 18, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Dementias With Lewy Bodies Drug: E2027 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Subjects
Actual Study Start Date : July 18, 2019
Actual Primary Completion Date : August 26, 2019
Estimated Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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.
Drug: E2027
E2027 oral capsule.




Primary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 56 post-dose ]
  9. Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 28 post-dose ]
  10. Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 28 post-dose ]

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 56 days post-dose ]
  2. Number of Participants With Clinically Significant Abnormal Laboratory Values [ Time Frame: Up to 56 days post-dose ]
  3. Number of Participants With Clinically Significant Abnormal Vital Sign Values [ Time Frame: Up to 56 days post-dose ]
  4. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings [ Time Frame: Up to 56 days post-dose ]
  5. Number of Participants With Clinically Significant Abnormal Physical Examination Findings [ Time Frame: Baseline, Up to 56 days post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023877


Locations
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United States, Wisconsin
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Eisai Inc.

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT04023877     History of Changes
Other Study ID Numbers: E2027-A001-005
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
E2027
[14C]E2027
Dementia with Lewy bodies
Dementia
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases