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Healthy VolunteersPhase 1NCT04493255

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

A Phase 1 study testing [14C]E7090 in people with Healthy Volunteers, run by Eisai Limited at 1 site in United Kingdom.

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 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. Read more about this study

Who is it for?
Ages 35 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
[14C]E7090
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 Kingdom
Study dates
9 Sep 2020to 21 Oct 2020
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 35 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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  • Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Covance Clinical Research Unit

    Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
[14C]E7090
Keywords
Healthy Participants, Phase 1, Pharmacokinetics

What participants receive

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

  • [14C]E7090Drug

    Also called E7090

    [14C]E7090, oral capsule.

Study groups in NCT04493255
Study groupRoleWhat they receive
E7090ExperimentalParticipants will receive 100 microcurie (μCi) of [14C]E7090 as a single 35 milligram (mg), capsule, orally on Day 1.
Receives: Drug: [14C]E7090

What is being measured

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

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

    Measured: Up to Day 57

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

    Measured: Up to Day 57

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

    Measured: Up to Day 57

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

    Measured: Up to Day 57

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

    Measured: 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

    Measured: Up to Day 57

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

    Measured: Day 1: 0-672 hours post-dose

  8. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 1: 0-672 hours post-dose

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

    Measured: Day 1: 0-672 hours post-dose

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

    Measured: Day 1: 0-672 hours post-dose

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

    Measured: 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

    Measured: Day 1: 0-672 hours post-dose

Secondary outcomes (8)

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

    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.

    Measured: Up to Day 57

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

    Measured: Baseline up to Day 57

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

    Measured: Baseline up to Day 29

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

    Measured: Baseline up to Day 29

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

    Measured: Baseline up to Day 29

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

    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.

    Measured: Baseline up to Day 29

  7. Number of Participants With Clinically Significant Change From Baseline in Ophthalmic Examinations

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

    Measured: Baseline up to Day 29

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

    Measured: Baseline up to Day 29

Timeline

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

  1. First posted30 Jul 2020
  2. Study start9 Sep 2020
  3. Primary completion21 Oct 2020
  4. Study completion21 Oct 2020

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04493255
Sponsor's protocol ID
E7090-E044-002
Other IDs
2019-004957-10, 2019
Status last verified
Jul 2020
First submitted
15 Jul 2020
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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 [14C]E7090 in people with Healthy Volunteers, run by Eisai Limited at 1 site in United Kingdom.

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 5 inclusion and 12 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 4 Feb 2021. 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 Kingdom. 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?

feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine (time frame: Up to Day 57). The study lists 15 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 NCT04493255.

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 4 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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