ClinicalTrials.gg
WithdrawnNCT04840927Updated Nov 24, 2023

A Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release (TR) Tablets Compared to an E7386 Immediate Release (IR) Tablet in Healthy Adult Participants

A Phase 1 interventional study of E7386 in Healthy Volunteers, sponsored by Eisai Limited. Withdrawn at 1 site in United Kingdom. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Eisai Limited · Phase 1, Interventional, and Other

Why this study was withdrawn
Delay in availability of IMP
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the pharmacokinetic (PK) profile of E7386 following oral administration of E7386 enteric coated TR prototype tablet formulations (TR1, TR2 and optional TR3) and to evaluate the relative bioavailability of E7386 TR tablets compared to E7386 IR reference tablet.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Relative Bioavailability
  • Pharmacoscintigraphic
  • Pharmacokinetic
  • E7386
03

In context

Lead sponsor

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

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

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
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. Healthy male or female (women of nonchildbearing potential [WNCBP]) aged greater than or equal to (>=) 30 years and less than or equal to (\<=) 55 years old inclusive at the time of signing
  2. (BMI) >=18.0 and \<=30.0 kilogram per square meter (kg/m\^2) as measured at screening
  3. Participants must demonstrate their ability to swallow an empty size 000 capsule (26.1*9.91 millimeter [mm]) at screening and must be willing and able to take the SmartPill\^Trade Mark (TM) (27*12 mm)
  4. Provide written informed consent
  5. Willing and able to comply with all aspects of the protocol
  6. Participant must have regular bowel movements (that is, average stool production of >=1 and \<=3 stools per day)
  7. Must agree to adhere to the requirements

Exclusion criteria

Exclusion Criteria:

  1. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years prior to Day -1 of Period 1. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
  2. Male participants with pregnant or breastfeeding partners
  3. Males who are unwilling to follow the rules of the study for up to 92 days after last dose of the study drug
  4. Females who are of or breastfeeding or pregnant at screening or admission/predose (as documented by a positive beta-human chorionic gonadotropin [or human chorionic gonadotropin {hCG} test with a minimum sensitivity of 25 international units per liter {IU/L} or equivalent units of beta-hCG {or hCG}]. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug)
  5. illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
  6. Evidence of disease that may influence the outcome of the study within 4 weeks of the participants first planned dose; example, disorders of the gastrointestinal (GI) tract especially peptic ulceration, GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome, liver, kidney, chronic respiratory system, dermatological system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism. Participants with Gilbert's Syndrome are not allowed
  7. Any history of GI or abdominal surgery or conditions that may affect absorption, metabolism or excretion of E7386 example, intestinal resections, hepatectomy, nephrectomy, digestive organ resection, fistulas or physiological/mechanical GI obstruction at screening
  8. to SmartPill\^TM use: history of gastric bezoar, swallowing disorders, suspected or known strictures, severe dysphagia to food or pills, Crohn's disease or diverticulitis
  9. Presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body. Very small metal items (example, sterilization clips, hernia repair staples) are permitted
  10. Acute diarrhea or constipation in the 7 days before the predicted Day 1. If screening occurs greater than (>) 7 days before the Day 1, this criterion will be determined on Day 1. Diarrhea will be defined as the passage of liquid feces and/or a stool frequency of >3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
  11. Any abnormal clinical symptom or organ impairment found by medical history at screening, and physical examinations, clinical laboratory tests and vital signs
  12. , total white cell count, neutrophils or below the lower limit of normal at screening. (ALT) >1.2* (ULN) that is, up to 60 IU/L (men) and 42 IU/L (women) at screening
  13. A prolonged /corrected QT (QTc) interval (corrected QT interval by Fridericia's formula [QTcF] >450 millisecond [msec]) as demonstrated by a repeated 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
  14. Known history of clinically significant drug or food allergies or presently experiencing any seasonal or perennial allergy at screening
  15. Positive surface antigen (HBsAg), virus antibody (HCV Ab) or (HIV) antibody results at screening
  16. History of 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
  17. Alcohol consumption in males >21 units per week and females >14 units per week (1 unit=1/2 pint beer, or a 25 milliliter (mL) shot of 40 percent (%) spirit, 1.5 to 2 units=125 mL glass of wine, depending on type)
  18. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of >10 parts per million (ppm) at screening or admission
  19. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
  20. Currently enrolled in another clinical study or used any drug or device within the 90 days prior to Day 1 or Period 1
  21. Participants who are, or are immediate family members of, a study site or sponsor employee
  22. Participants who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening
  23. Receipt of blood products within 4 weeks of dosing, or donation of blood or plasma within the previous 3 months or loss of >400 mL of blood
  24. Use of recreational drugs is prohibited
  25. Use of any prescription drugs/herbal remedies or over-the-counter medications within 4 weeks or 14 days, respectively, before dosing (other than occasional use of up to 4 gram of paracetamol per day)
  26. Any history of or concomitant medical condition that in the opinion of the investigator would compromise the participants ability to safely complete the study
  27. Any lifetime history of psychiatric disease (including but not limited to depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, anxiety disorders [if ever treated with medication]). The absence of a history of psychiatric disease should be documented by a checklist in the electronic case report form
  28. Any lifetime suicidal behavior or ideation (per the Suicidal Behavior section of the Columbia-Suicide Severity Rating Scale [C-SSRS]) at screening
  29. History or ongoing psychiatric disorder or psychiatric symptoms as evaluated by a physician at screening. Whenever possible, medical records should be reviewed to determine any history of psychiatric disorder or use of medications to treat psychiatric disorders
  30. Evidence of current corona virus disease (COVID) 19 infection or ongoing/unrecovered sequelae COVID-19
  31. Failure to satisfy the investigator of fitness to participate for any other reason
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Cohort 1: E7386 40 mg

    Participants will be randomized to one of the 3 treatment sequences: Treatment sequence 1: Participants will receive Regimen A on Day 1 of treatment period 1 then Regimen B on Day 1 of treatment period 2 then Regimen C on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. Treatment sequence 2: Participants will receive Regimen B on Day 1 of treatment period 1 then Regimen C on Day 1 of treatment period 2 then Regimen A on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. Treatment sequence 3: Participants will receive Regimen C on Day 1 of treatment period 1 then Regimen A on Day 1 of treatment period 2 then Regimen B on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. A maximum wash out period of 10 days will be maintained between treatment periods 1, 2 and 3.

    Drug: E7386

  • Experimental
    Cohort 2: E7386 40 mg

    Participants will be randomized to one of the 3 treatment sequences: Treatment sequence 4: Participants will receive Regimen C on Day 1 of treatment period 1 then Regimen B on Day 1 of treatment period 2 then Regimen A on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. Treatment sequence 5: Participants will receive Regimen A on Day 1 of treatment period 1 then Regimen C on Day 1 of treatment period 2 then Regimen B on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. Treatment sequence 6: Participants will receive Regimen B on Day 1 of treatment period 1 then Regimen A on Day 1 of treatment period 2 then Regimen C on Day 1 of treatment period 3 and an optional Regimen D on Day 1 of an optional treatment period 4. A maximum wash out period of 10 days will be maintained between treatment periods 1, 2 and 3.

    Drug: E7386

Interventions

  • DrugE7386

    Regimen A: 40 milligram (mg) IR Oral Tablet.

06

What researchers measure

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for E7386

    Time frame: Day 1: 0-48 hours post-dose

  2. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386

    Time frame: Day 1: 0-48 hours post-dose

  3. AUC (0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386

    Time frame: Day 1: 0-48 hours post-dose

  4. AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for E7386

    Time frame: Day 1: 0-48 hours post-dose

  5. T1/2: Terminal Elimination Phase Half-life for E7386

    Time frame: Day 1: 0-48 hours post-dose

  6. CL/F: Apparent Total Clearance Following Extravascular Administration for E7386

    Time frame: Day 1: 0-48 hours post-dose

  7. Vz/F: Apparent Volume of Distribution at Terminal Phase for E7386

    Time frame: Day 1: 0-48 hours post-dose

07

Study locations

1 site
  • Quotient Sciences
    Nottingham, 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

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2021 to primary completion in May 2023, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2021
First posted
Apr 12, 2021
StartActual
Apr 9, 2021
Primary completionActual
May 17, 2023
CompletionActual
May 17, 2023
Last update
Nov 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04840927
Lead sponsor
Eisai Limited
Responsible party
Sponsor
First posted
Apr 12, 2021
Start date
Apr 9, 2021
Primary completion
May 17, 2023
Completion
May 17, 2023
Last update
Nov 24, 2023

Oversight

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

Not currently enrolling

This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: E-7386

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