A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants

February 3, 2021 updated by: Eisai Limited

An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Subjects

The primary objective of this study is to determine the pharmacokinetics (PK) and excretion of E7090 and its metabolites in healthy male participants. Also, to assess the safety and tolerability of a single dose of E7090 in healthy male participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
      • Leeds, United Kingdom, LS2 9LH
        • Covance Clinical Research Unit

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Non-smoking, healthy males, age greater than or equal to (>=) 35 years and less than or equal to (<=) 55 years old at the time of informed consent
  2. Body Mass Index (BMI) of >=18 to <=32 kilogram per square meter (kg/m^2) at Screening
  3. Provide written informed consent
  4. Willing and able to comply with all aspects of the protocol
  5. History of a minimum of 1 bowel movement per day

Exclusion Criteria:

  1. Participant has participated in any clinical research study involving a radiolabeled investigational product within the 12 months prior to Day -1 (Baseline)
  2. Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090
  3. Participant has had exposure to significant diagnostic or therapeutic radiation (example: serial x-ray, computed tomography scan, barium meal) or has current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1

  4. Participant has the following ocular disorders:

    1. Any previous history or current evidence of corneal disorder
    2. Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease)
  5. Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1)
  6. Participants has a known history of food allergies or significant seasonal or perennial allergy
  7. Participants is known to be human immunodeficiency virus positive at Screening
  8. Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening
  9. Participant has a poor peripheral venous access, in the opinion of the investigator (or designee)
  10. Participant received blood products within 2 months prior to Day -1, or donation of blood within 3 months prior to Screening, donation of plasma within 2 weeks prior to Screening, or donation of platelets from 6 weeks prior to Screening

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: E7090
Participants will receive 100 microcurie (μCi) of [14C]E7090 as a single 35 milligram (mg), capsule, orally on Day 1.
Drug: [14C]E7090
[14C]E7090, oral capsule.
Other Names:
  • E7090

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine
Time Frame: Up to Day 57
Up to Day 57
Cumulative feu: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine From 0 to tlast Hours
Time Frame: Up to Day 57
Up to Day 57
fef: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces
Time Frame: Up to Day 57
Up to Day 57
Cumulative fef: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces From 0 to tlast Hours
Time Frame: Up to Day 57
Up to Day 57
feu+ef: Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces)
Time Frame: Up to Day 57
Up to Day 57
Cumulative feu+ef: Cumulative Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces) From 0 to tlast Hours
Time Frame: Up to Day 57
Up to Day 57
Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites
Time Frame: Day 1: 0-672 hours post-dose
Day 1: 0-672 hours post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites
Time Frame: Day 1: 0-672 hours post-dose
Day 1: 0-672 hours post-dose
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for [14C]E7090, E7090 and its Metabolites
Time Frame: Day 1: 0-24 hours post-dose
Day 1: 0-24 hours post-dose
AUC(0-t): Area Under the Concentration- time Curve From Time 0 to Time of Last Quantifiable Concentration for [14C]E7090, E7090 and its Metabolites
Time Frame: Day 1: 0-672 hours post-dose
Day 1: 0-672 hours post-dose
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]E7090, E7090 and its Metabolites
Time Frame: Day 1: 0-672 hours post-dose
Day 1: 0-672 hours post-dose
T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites
Time Frame: Day 1: 0-672 hours post-dose
Day 1: 0-672 hours post-dose
CL/F: Apparent Total Body Clearance for E7090
Time Frame: Day 1: 0-672 hours post-dose
Day 1: 0-672 hours post-dose
Vd/F: Apparent Volume of Distribution for E7090
Time Frame: Day 1: 0-672 hours post-dose
Day 1: 0-672 hours post-dose
MPR AUC(0-inf): Metabolite to Parent Ratio For AUC(0-inf) of Metabolite to E7090, Corrected for Molecular Weights
Time Frame: Day 1: 0-672 hours post-dose
Day 1: 0-672 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolic profile of E7090: Concentration of Metabolite of E7090 in Plasma, Urine, and Feces
Time Frame: Up to Day 57
Blood, urine and feces samples will be collected and analyzed to estimate the concentration of metabolite of E7090 by Liquid Chromatography/ multiple-stage Mass Spectroscopy method.
Up to Day 57
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline up to Day 57
Baseline up to Day 57
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values
Time Frame: Baseline up to Day 29
Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
Time Frame: Baseline up to Day 29
Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in 12 Lead Electrocardiogram (ECG) Findings
Time Frame: Baseline up to Day 29
Baseline up to Day 29
Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline up to Day 29
The C-SSRS is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality will be reported for this outcome measure.
Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Ophthalmic Examinations
Time Frame: Baseline up to Day 29
Ophthalmic examinations includes visual acuity, funduscopy, optical coherence tomography, and slit-lamp examination.
Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
Time Frame: Baseline up to Day 29
Baseline up to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Limited

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7090-E044-002
  • 2019-004957-10 (EudraCT Number)

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

No

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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