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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04023877
Recruitment Status : Active, not recruiting
First Posted : July 18, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE July 18, 2019
Estimated Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2019)
  • 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.
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 56 post-dose ]
  • Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 28 post-dose ]
  • Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 28 post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces) [ Time Frame: Up to 56 days ]
    Blood, urine, and feces samples will be collected at specific time points and will be analyzed for the amount of radiolabeled [14C]E2027.
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 56 post-dose ]
  • Apparent Volume of Distribution (Vz/F) of E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 28 post-dose ]
  • Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices [ Time Frame: Pre-dose up to Day 28 post-dose ]
Change History Complete list of historical versions of study NCT04023877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 56 days post-dose ]
  • Number of Participants With Clinically Significant Abnormal Laboratory Values [ Time Frame: Up to 56 days post-dose ]
  • Number of Participants With Clinically Significant Abnormal Vital Sign Values [ Time Frame: Up to 56 days post-dose ]
  • Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings [ Time Frame: Up to 56 days post-dose ]
  • Number of Participants With Clinically Significant Abnormal Physical Examination Findings [ Time Frame: Baseline, Up to 56 days post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants
Official Title  ICMJE An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dementias With Lewy Bodies
Intervention  ICMJE Drug: E2027
E2027 oral capsule.
Study Arms  ICMJE 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.
Intervention: Drug: E2027
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 16, 2019)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 12, 2019
Estimated Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023877
Other Study ID Numbers  ICMJE E2027-A001-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/.
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP