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Completed

NCT Number: NCT04493255

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Body Mass Index (BMI) of >=18 to <=32 kilogram per square meter (kg/m^2) at Screening
  • Provide written informed consent
  • Willing and able to comply with all aspects of the protocol
  • History of a minimum of 1 bowel movement per day

Exclusion criteria

  • Participant has participated in any clinical research study involving a radiolabeled investigational product within the 12 months prior to Day -1 (Baseline)
  • Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090
  • 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
  • Participant has the following ocular disorders:
  • Any previous history or current evidence of corneal disorder
  • Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease)
  • Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1)
  • Participants has a known history of food allergies or significant seasonal or perennial allergy
  • Participants is known to be human immunodeficiency virus positive at Screening
  • Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening
  • Participant has a poor peripheral venous access, in the opinion of the investigator (or designee)
  • 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

Treatment and study plan

[14C]E7090

Drug

[14C]E7090, oral capsule.

Other names: E7090

Primary outcomes

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

    Time frame: Up to Day 57

  2. 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

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

    Time frame: Up to Day 57

  4. 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

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

    Time frame: 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

    Time frame: Up to Day 57

  7. Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites

    Time frame: Day 1: 0-672 hours post-dose

  8. 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

  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

    Time frame: 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

    Time frame: 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

    Time frame: Day 1: 0-672 hours post-dose

  12. T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites

    Time frame: Day 1: 0-672 hours post-dose

  13. CL/F: Apparent Total Body Clearance for E7090

    Time frame: Day 1: 0-672 hours post-dose

  14. Vd/F: Apparent Volume of Distribution for E7090

    Time frame: 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

    Time frame: Day 1: 0-672 hours post-dose

Secondary outcomes

  1. 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.

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline up to Day 57

  3. Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values

    Time frame: Baseline up to Day 29

  4. Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values

    Time frame: Baseline up to Day 29

  5. Number of Participants With Clinically Significant Change From Baseline in 12 Lead Electrocardiogram (ECG) Findings

    Time frame: Baseline up to Day 29

  6. 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.

  7. 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.

  8. Number of Participants With Clinically Significant Change From Baseline in Physical Examinations

    Time frame: Baseline up to Day 29

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2020
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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