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Dementias With Lewy BodiesPhase 1NCT04023877

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

A Phase 1 study testing E2027 in people with Dementias With Lewy Bodies, run by Eisai Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Dementias With Lewy Bodies
What is being tested?
E2027
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
18 Jul 2019to 11 Oct 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit Inc.

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: 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.

Being tested
E2027
Keywords
E2027, [14C]E2027, Dementia with Lewy bodies, Dementia
Medical subject headings
Lewy Body Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2027Drug

    E2027 oral capsule.

Study groups in NCT04023877
Study groupRoleWhat they receive
E2027ExperimentalParticipants will receive approximately 130 microcurie (μCi) of [14C]E2027 as a single 50 milligram (mg) (free base), capsule, orally on Day 1.
Receives: Drug: E2027

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue)

    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.

    Measured: Up to 56 days

  2. Maximum Concentration (Cmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Pre-dose up to Day 56 post-dose

  8. Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices

    Measured: Pre-dose up to Day 56 post-dose

  9. Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices

    Measured: Pre-dose up to Day 28 post-dose

  10. Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices

    Measured: Pre-dose up to Day 28 post-dose

Secondary outcomes (5)

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to 56 days post-dose

  2. Number of Participants With Clinically Significant Abnormal Laboratory Values

    Measured: Up to 56 days post-dose

  3. Number of Participants With Clinically Significant Abnormal Vital Sign Values

    Measured: Up to 56 days post-dose

  4. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings

    Measured: Up to 56 days post-dose

  5. Number of Participants With Clinically Significant Abnormal Physical Examination Findings

    Measured: Baseline, Up to 56 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2019
  2. Study start18 Jul 2019
  3. Primary completion11 Oct 2019
  4. Study completion11 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04023877
Sponsor's protocol ID
E2027-A001-005
Status last verified
Jul 2019
First submitted
16 Jul 2019
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E2027 in people with Dementias With Lewy Bodies, run by Eisai Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue) (time frame: Up to 56 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04023877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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