AzTrials
AzTrials

Healthy VolunteersPhase 1NCT05607537

A Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of Carbon-14 (14C)E7386 in Healthy Male Participants

A Phase 1 study testing E7386 Tablet, (14C)E7386 Capsule and (14C)E7386 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
Search all trials

Trial summary

The primary purpose of this study is to evaluate the absolute bioavailability of E7386 following a single oral dose of E7386 as a one 40 milligram (mg) immediate release (IR) tablet and concomitant intravenous (IV) microdose of (14C)E7386 (100 mcg [microgram]) solution for Part 1 and to determine the pharmacokinetic… Read more about this study

Who is it for?
Ages 30 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
E7386 Tablet, (14C)E7386 Capsule and (14C)E7386
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
17 Oct 2022to 31 Aug 2023
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 30 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Non-smoking, healthy male, age greater than or equal to (>=) 30 years and less than or equal to (<=) 55 years old at the time of informed consent
  • Body Mass Index (BMI) of greater than (>) 18 to less than (<) 30 kilogram per square meter (kg/m^2) as measured at Screening
  • Adequate organ function per blood work
  • Participant must have regular bowel movements (that is, average stool production of >=1 and <=3 stools per day)
  • Participant must agree to adhere to the contraception requirements

Who cannot join

  • Have participated in any clinical research study involving nonradiolabeled investigational product within 90 days prior to Day -1 (Baseline) or involving radiolabeled investigational product within 12 months prior to Day -1 (Baseline)
  • Participant has had exposure to significant diagnostic or therapeutic radiation (example, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1 (Baseline)
  • Male participant with pregnant or breastfeeding partner
  • Male participant who is unwilling to follow the contraception rules of the study for up to 92 days after last dose of the study drug
  • Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks prior to dosing
  • A prolonged QT/QTc interval (QTcF [corrected QT interval by Fridericia] >450 millisecond [ms]) as confirmed by a repeated ECG at Screening or Baseline, or a history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome), or the use of concomitant medications that prolonged the QT/QTc interval
Show all 14Show fewer
  • Known history of clinically significant drug, food allergies, or presently experiencing any seasonal or perennial allergy at Screening and Baseline (Day -1)
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus (HIV) antibody at Screening
  • History of recreational drug use, drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or admission
  • Participant who is, or is an immediate family member of, a study site or sponsor employee
  • Participant does not have suitable veins for multiple venipunctures/cannulations as assessed by the investigator or delegate at Screening
  • Receipt of blood products within 4 weeks prior to dosing, or donation of blood or plasma within the previous 3 months, or loss of greater than 400 mL of blood
  • Any history of or concomitant medical condition that in the opinion of the investigator would compromise the participant's ability to safely complete the study at Screening and Day -1 (Baseline)
  • Failure to satisfy the investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Labcorp Clinical Research Unit

    Leeds, LS11 9EH

Other trials in United Kingdom

About this study

Official title: An Open-Label, Single-Center, 2-Part, Parallel Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of [14C]E7386 in Healthy Male Subjects

The primary purpose of this study is to evaluate the absolute bioavailability of E7386 following a single oral dose of E7386 as a one 40 milligram (mg) immediate release (IR) tablet and concomitant intravenous (IV) microdose of (14C)E7386 (100 mcg [microgram]) solution for Part 1 and to determine the pharmacokinetic (PK) and excretion of E7386 following a single 40 mg powder in capsule (PIC) oral administration of (14C)E7386 for Part 2.

Being tested
E7386 Tablet, (14C)E7386 Capsule, (14C)E7386
Keywords
E7386

What participants receive

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

  • E7386 TabletDrug

    E7386 40 mg tablet.

  • (14C)E7386 CapsuleDrug

    (14C)E7386 40 mg capsule.

  • (14C)E7386Drug

    (14C)E7386 administered intravenously.

Study groups in NCT05607537
Study groupRoleWhat they receive
Part 1: E7386 40 mg Tablet + (14C)E7386ExperimentalParticipants will be administered a single oral dose of E7386 40 mg tablet on Day 1 followed by an intravenous infusion containing a microdose solution of [14C]E7386 (100 mcg) with not more than (NMT) 7.4 kilobecquerel (kBq) (0.20 microcurie [mcCi]), starting approximately 25 minutes post oral dose administered as 5 milliliter (mL) over 5 minutes to coincide with the time at which the highest drug concentration occurs (tmax) for E7386 after an oral dose.
Receives: Drug: E7386 Tablet; Drug: (14C)E7386
Part 2: (14C)E7386 40 mg CapsuleExperimentalParticipants will be administered a single oral dose of E7386 40 mg capsule radiolabeled with approximately 2.96 megabecquerel (MBq) (80 mcCi) (14C)E7386 (final dose to depend on the specific activity of [14C]E7386) in the morning on Day 1 after an overnight fasting.
Receives: Drug: (14C)E7386 Capsule

What is being measured

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

  1. Part 1, %F: Percent Absolute Oral Bioavailability for (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  2. Part 1, Cmax: Maximum Observed Plasma Concentration for Total Radioactivity, (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  3. Part 1, Tlag: Time Delay Between Drug Administration and the Onset of Absorption for Total Radioactivity, (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  4. Part 1, Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for Total Radioactivity, (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  5. Part 1, AUC(0-12h): Area Under the Plasma Concentration-time Curve From Time Zero to 12 hours Post-dose for Total Radioactivity, (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 12 hours post-dose

  6. Part 1, AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for Total Radioactivity, (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 24 hours post-dose

  7. Part 1, AUC(0-last): Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Measurable Concentration for Total Radioactivity, (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  8. Part 1, AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time for Total Radioactivity, (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  9. Part 1, t1/2: Apparent Terminal Elimination Phase Half-life for Total Radioactivity, (14C)E7386 and E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  10. Part 1, MRT: Mean Residence Time of (14C)E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  11. Part 1, CL: Total Clearance of (14C)E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  12. Part 1, CL/F: Apparent Total Body Clearance of E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  13. Part 1, Vss: Volume of Distribution at Steady State of (14C)E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  14. Part 1, Vz/F: Apparent Volume of Distribution at Terminal Phase of E7386

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  15. Part 1, Fa: Percentage of Absorbed Dose Using Total Radioactivity in Urine

    Measured: Pre-dose (0 hour) up to 96 hours post-dose

  16. Part 2, Cmax: Maximum Observed Concentration for Total Radioactivity and E7386

    Measured: Pre-dose (0 hour) up to 480 hours post-dose

  17. Part 2, Tlag: Time Delay Between Drug Administration and the Onset of Absorption for Total Radioactivity and E7386

    Measured: Pre-dose (0 hour) up to 480 hours post-dose

  18. Part 2, Tmax: Time to Reach Maximum Observed Concentration (Cmax) for Total Radioactivity and E7386

    Measured: Pre-dose (0 hour) up to 480 hours post-dose

  19. Part 2, AUC(0-12h): Area Under the Concentration-time Curve From Time Zero to 12 hours Post-dose for Total Radioactivity and E7386

    Measured: Pre-dose (0 hour) up to 12 hours post-dose

  20. Part 2, AUC(0-24h): Area Under the Concentration-time Curve From Time Zero to 24 hours Post-dose for Total Radioactivity and E7386

    Measured: Pre-dose (0 hour) up to 24 hours post-dose

  21. Part 2, AUC(0-last): Area Under the Concentration-time Curve from Time 0 to Time of the Last Measurable Concentration for Total Radioactivity and E7386

    Measured: Pre-dose (0 hour) up to 480 hours post-dose

  22. Part 2, AUC(0-inf): Area Under the Concentration-time Curve From Time Zero to Infinite Time for Total Radioactivity and E7386

    Measured: Pre-dose (0 hour) up to 480 hours post-dose

  23. Part 2, t1/2: Apparent Terminal Elimination Phase Half-life for Total Radioactivity and E7386

    Measured: Pre-dose (0 hour) up to 480 hours post-dose

  24. Part 2, CL/F: Apparent Total Body Clearance of E7386

    Measured: Pre-dose (0 hour) up to 480 hours post-dose

  25. Part 2, Vz/F: Apparent Volume of Distribution at Terminal Phase of E7386

    Measured: Pre-dose (0 hour) up to 480 hours post-dose

  26. Part 2, feu: Percentage of Administered Radioactive Dose Excreted in Urine for Total Radioactivity

    Measured: Day -1 (Baseline) up to Day 49

  27. Part 2, Cumulative feu(0-tlast): Cumulative Radioactive Dose Excreted in Urine From Time 0 to Time of the Last Measurable Concentration

    Measured: Day -1 (Baseline) up to Day 49

  28. Part 2, fef: Percentage of Total Radioactivity Recovered in Feces Relative to the Administered Radioactive Dose

    Measured: Day -1 (Baseline) up to Day 49

  29. Part 2, Cumulative fef(0-tlast): Cumulative Radioactive Dose Excreted in Feces From Time 0 to Time of the Last Measurable Concentration

    Measured: Day -1 (Baseline) up to Day 49

  30. Part 2, feu+ef: Percentage of Total Radioactivity Recovered in Combined Urine and Feces Relative to the Administered Radioactive Dose

    Measured: Day -1 (Baseline) up to Day 49

  31. Part 2, Cumulative feu+ef(0-tlast): Cumulative Radioactive Dose excreted in Combined Excreta (Urine and Feces) From Time Zero to Time of the Last Measurable Concentration

    Measured: Day -1 (Baseline) up to Day 49

  32. Part 2, Fa: Percentage of Absorbed Dose Using Total Radioactivity in Urine

    Measured: Day -1 (Baseline) up to Day 49

Secondary outcomes (9)

  1. Part 2 (Metabolic Profile of E7386): Concentration of Metabolite of E7386 in Plasma, Urine, and Feces

    Blood, urine and feces samples will be collected and analyzed to estimate the concentration of metabolite of E7386 by liquid chromatography/multiple-stage mass spectroscopy method.

    Measured: Day 1 up to Day 21

  2. Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Part 1: Up to Day 5; Part 2: Up to Day 49

  3. Parts 1 and 2: Number of Participants With Abnormal Laboratory Values

    Laboratory assessment will include hematology, clinical chemistry, and urinalysis parameters.

    Measured: Part 1: Up to Day 5; Part 2: Up to Day 49

  4. Parts 1 and 2: Number of Participants With Abnormal Vital Signs Values

    Vital sign measurements will include systolic and diastolic blood pressure (BP), pulse rate, respiratory rate, body temperature.

    Measured: Part 1: Up to Day 5; Part 2: Up to Day 49

  5. Parts 1 and 2: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values

    Measured: Part 1: Up to Day 5; Part 2: Up to Day 49

  6. Parts 1 and 2: Number of Participants With Abnormal Ophthalmic Examinations

    Measured: Part 1: Up to Day 5; Part 2: Up to Day 49

  7. Parts 1 and 2: Number of Participants who will Receive Concomitant Medications

    Measured: Part 1: Up to Day 5; Part 2: Up to Day 49

  8. Parts 1 and 2: Number of Participants With Abnormal Physical Examinations

    Measured: Part 1: Up to Day 5; Part 2: Up to Day 49

  9. Parts 1 and 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)

    The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior is indicated 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 is indicated 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.

    Measured: Part 1: Up to Day 5; Part 2: Up to Day 49

Timeline

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

  1. First posted7 Nov 2022
  2. Study start17 Oct 2022
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607537
Sponsor's protocol ID
E7386-E044-003
Other IDs
2022-000954-27
Status last verified
Sep 2022
First submitted
14 Oct 2022
Last updated
21 Sep 2023
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 E7386 Tablet, (14C)E7386 Capsule and (14C)E7386 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 14 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 21 Sep 2023. 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?

Part 1, %F: Percent Absolute Oral Bioavailability for (14C)E7386 and E7386 (time frame: Pre-dose (0 hour) up to 96 hours post-dose). The study lists 32 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 NCT05607537.

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 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in