Clincosm LogoSign in Get a demo

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

Sponsor
Eisai Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04493255
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
1.4
Actual Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Subjects
Actual Study Start Date :
Sep 9, 2020
Actual Primary Completion Date :
Oct 21, 2020
Actual Study Completion Date :
Oct 21, 2020

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine [Up to Day 57]

    2. Cumulative feu: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine From 0 to tlast Hours [Up to Day 57]

    3. fef: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces [Up to Day 57]

    4. Cumulative fef: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces From 0 to tlast Hours [Up to Day 57]

    5. feu+ef: Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces) [Up to Day 57]

    6. Cumulative feu+ef: Cumulative Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces) From 0 to tlast Hours [Up to Day 57]

    7. Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites [Day 1: 0-672 hours post-dose]

    8. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites [Day 1: 0-672 hours post-dose]

    9. AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for [14C]E7090, E7090 and its Metabolites [Day 1: 0-24 hours post-dose]

    10. 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 [Day 1: 0-672 hours post-dose]

    11. AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]E7090, E7090 and its Metabolites [Day 1: 0-672 hours post-dose]

    12. T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites [Day 1: 0-672 hours post-dose]

    13. CL/F: Apparent Total Body Clearance for E7090 [Day 1: 0-672 hours post-dose]

    14. Vd/F: Apparent Volume of Distribution for E7090 [Day 1: 0-672 hours post-dose]

    15. MPR AUC(0-inf): Metabolite to Parent Ratio For AUC(0-inf) of Metabolite to E7090, Corrected for Molecular Weights [Day 1: 0-672 hours post-dose]

    Secondary Outcome Measures

    1. Metabolic profile of E7090: Concentration of Metabolite of E7090 in Plasma, Urine, and Feces [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.

    2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Baseline up to Day 57]

    3. Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values [Baseline up to Day 29]

    4. Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values [Baseline up to Day 29]

    5. Number of Participants With Clinically Significant Change From Baseline in 12 Lead Electrocardiogram (ECG) Findings [Baseline up to Day 29]

    6. Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) [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.

    7. Number of Participants With Clinically Significant Change From Baseline in Ophthalmic Examinations [Baseline up to Day 29]

      Ophthalmic examinations includes visual acuity, funduscopy, optical coherence tomography, and slit-lamp examination.

    8. Number of Participants With Clinically Significant Change From Baseline in Physical Examinations [Baseline up to Day 29]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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:

    5. Any previous history or current evidence of corneal disorder

    6. Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease)

    7. Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1)

    8. Participants has a known history of food allergies or significant seasonal or perennial allergy

    9. Participants is known to be human immunodeficiency virus positive at Screening

    10. Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening

    11. Participant has a poor peripheral venous access, in the opinion of the investigator (or designee)

    12. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Clinical Research Unit Leeds United Kingdom LS2 9LH

    Sponsors and Collaborators

    • Eisai Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Limited
    ClinicalTrials.gov Identifier:
    NCT04493255
    Other Study ID Numbers:
    • E7090-E044-002
    • 2019-004957-10
    First Posted:
    Jul 30, 2020
    Last Update Posted:
    Feb 4, 2021
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eisai Limited
    Healthy Participants
    Phase 1
    Pharmacokinetics

    Study Results

    No Results Posted as of Feb 4, 2021