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CompletedNCT05607537Updated Sep 21, 2023

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 interventional study of E7386 Tablet and (14C)E7386 Capsule in Healthy Volunteers, sponsored by Eisai Limited. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Eisai Limited · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
30 Years to 55 Years
Sex
Male
01

Study 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 (PK) and excretion of E7386 following a single 40 mg powder in capsule (PIC) oral administration of (14C)E7386 for Part 2.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • E7386
03

In context

Lead sponsor

Eisai Limited is the lead sponsor of 48 studies on the registry; 2 are open to participants now.

Browse Eisai Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Body Mass Index (BMI) of greater than (>) 18 to less than (\<) 30 kilogram per square meter (kg/m\^2) as measured at Screening
  3. Adequate organ function per blood work
  4. Participant must have regular bowel movements (that is, average stool production of >=1 and \<=3 stools per day)
  5. Participant must agree to adhere to the contraception requirements

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. 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)
  3. Male participant with pregnant or breastfeeding partner
  4. 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
  5. 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
  6. 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
  7. Known history of clinically significant drug, food allergies, or presently experiencing any seasonal or perennial allergy at Screening and Baseline (Day -1)
  8. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus (HIV) antibody at Screening
  9. 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
  10. Participant who is, or is an immediate family member of, a study site or sponsor employee
  11. Participant does not have suitable veins for multiple venipunctures/cannulations as assessed by the investigator or delegate at Screening
  12. 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
  13. 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)
  14. Failure to satisfy the investigator of fitness to participate for any other reason
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Part 1: E7386 40 mg Tablet + (14C)E7386

    Participants 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.

    Drug: E7386 Tablet · Drug: (14C)E7386

  • Experimental
    Part 2: (14C)E7386 40 mg Capsule

    Participants 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.

    Drug: (14C)E7386 Capsule

Interventions

06

What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

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

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

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

    Time frame: 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

    Time frame: 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

    Time frame: Day -1 (Baseline) up to Day 49

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day -1 (Baseline) up to Day 49

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

    Time frame: Day -1 (Baseline) up to Day 49

Secondary outcomes

  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.

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49

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

    Time frame: 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

    Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49

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

    Time frame: 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.

    Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49

07

Study locations

1 site
  • Labcorp Clinical Research Unit
    Leeds, LS11 9EH, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05607537
Lead sponsor
Eisai Limited
Responsible party
Sponsor
First posted
Nov 7, 2022
Start date
Oct 17, 2022
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Sep 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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