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Food Effect in Healthy ParticipantsPhase 1NCT03996226

A Food-Effect Study of E7386 in Healthy Participants

A Phase 1 study testing E7386 in people with Food Effect in Healthy Participants, run by Eisai Inc. at 1 site in United States.

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 effect of food in healthy participants on the bioavailability of E7386 following single dose administration with and without a meal. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Food Effect in Healthy Participants
What is being tested?
E7386
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
7 Jun 2019to 29 Oct 2019
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Non-smoking, healthy participants at the time of informed consent.
  • Body Mass Index (BMI) greater than (>) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) at Screening.

Who cannot join

  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 international units per litre (IU/L) or equivalent units of ß-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
  • Females of childbearing potential who:
  • Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
  • total abstinence (if it is their preferred and usual lifestyle)
  • an intrauterine device or intrauterine hormone-releasing system
  • a contraceptive implant
Show all 27Show fewer
  • an oral contraceptive (with additional barrier method) (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation)
  • have a vasectomized partner with confirmed azoospermia
  • Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
  • Males who have not had a successful vasectomy (confirmed azoospermia) and their female partners meet the exclusion criteria No: 2, above. If the female partner is pregnant, then males who do not agree to use Barrier contraception (latex or synthetic condoms) throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation
  • Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
  • Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
  • Any history of major surgery, e.g., intestinal resections, hepatectomy, nephrectomy, digestive organ resection that may affect absorption, metabolism or excretion of E7386.
  • Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening
  • Clinically significant ECG abnormality including a marked baseline prolongation of QT/corrected QT interval (QTc) (example: repeated demonstration of a QTc interval greater than (>) 500 milliseconds [msec]), or a family history of prolonged QTc syndrome or sudden death
  • History of drug or alcohol misuse within 6 months prior to Screening, or who had a positive urine drug test at Screening or Baseline
  • Diagnosed with acquired immune deficiency syndrome, or test positive for human immunodeficiency virus (HIV) at screening
  • Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening
  • Use of prescription drugs within 4 weeks prior to dosing
  • Intake of over-the-counter medications within 2 weeks prior to dosing
  • Intake of caffeinated beverages or food within 72 hours prior to dosing
  • Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing
  • Participated in another clinical trial less than 4 weeks prior to dosing or was currently enrolled in another clinical trial
  • Consumed grapefruit, starfruit, Seville oranges or their products within 7 days prior to dosing
  • Consumed herbal preparations/medications including but not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng within 7 days prior to dosing
  • Allergic to E7386 or any of the tablet's ingredients
  • Known history of clinically significant drug or food allergies, or presently experiencing significant seasonal or perennial allergy at Screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1 Food-Effect Study of E7386 in Healthy Subjects

The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of E7386 following single dose administration with and without a meal.

Being tested
E7386
Keywords
Healthy Participants, E7386, Bioavailability, Food Effect

What participants receive

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

  • E7386Drug

    E7386 oral tablets.

Study groups in NCT03996226
Study groupRoleWhat they receive
E7386: Fed + FastExperimentalParticipants will receive a single oral dose of E7386 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of E7386 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
Receives: Drug: E7386
E7386: Fast + FedExperimentalParticipants will receive a single oral dose of E7386 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of E7386 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
Receives: Drug: E7386

What is being measured

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

  1. Cmax: Maximum Observed Plasma Concentration for E7386

    Measured: Day 1: 0-48 hours; Day 8: 0-48 hours

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

    Measured: Day 1: 0-48 hours; Day 8: 0-48 hours

  3. AUC0-t: AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386

    Measured: Day 1: 0-48 hours; Day 8: 0-48 hours

  4. AUC0-inf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for E7386

    Measured: Day 1: 0-48 hours; Day 8: 0-48 hours

Timeline

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

  1. First posted24 Jun 2019
  2. Study start7 Jun 2019
  3. Primary completion29 Oct 2019
  4. Study completion29 Oct 2019

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03996226
Sponsor's protocol ID
E7386-A001-001
Status last verified
Jun 2019
First submitted
21 Jun 2019
Last updated
14 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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 in people with Food Effect in Healthy Participants, run by Eisai Inc. at 1 site in United States.

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 2 inclusion and 27 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 14 Nov 2019. 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 States. 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?

Cmax: Maximum Observed Plasma Concentration for E7386 (time frame: Day 1: 0-48 hours; Day 8: 0-48 hours). The study lists 4 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 NCT03996226.

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 14 Nov 2019.

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