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Healthy ParticipantsPhase 1NCT04565574

A Study to Assess the Effect of Food Intake and Drug-drug Interactions of E7090 When Co-administered With Rabeprazole or Rifampin in Healthy Participants

A Phase 1 study testing E7090, Rabeprazole 20 mg and Rifampin 600 mg in people with Healthy Participants, run by Eisai Co., Ltd. at 1 site in Japan.

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

This study will have three parts: Part A, Part B, and Part C. The primary purpose of Part A is to evaluate the effect of food on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part B is to evaluate the effects of rabeprazole (a gastric acid-reducing agent) on the… Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
E7090, Rabeprazole 20 mg and Rifampin 600 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteJapan
Study dates
16 Oct 2020to 31 Mar 2021
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 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants who meet all of the following criteria will be eligible for participation in the study
  • 1. Body mass index (BMI) between 18.5 to 25.0 kilogram per square meter (kg/m^2), inclusive, at screening

Who cannot join

  • Participants who meet any of the following criteria will be excluded from this study:
  • Following ocular disorders
  • Current evidence of Grade 2 or higher corneal disorder
  • Current evidence of active macular disorder (example, age-related macular degeneration, central serous chorioretinal disease)
  • 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
  • A prolonged QT/QTc interval (QT interval with Fridericia's correction [QTcF] greater than [>] 480 millisecond [ms]) demonstrated on ECG at screening or baseline
  • Known history of food allergies or presently experiencing significant seasonal or perennial allergy at screening
  • Known history of allergies or reactions to rabeprazole or rifampin or known anaphylactic reaction to any drugs at screening

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Eisai trial site #1

    Minatoku, Tokoyo

Other trials in Japan

About this study

Official title: An Open-Label, Single-Dose Study to Assess the Effect of Food Intake and Drug-Drug Interactions of E7090 When Co-administered With Rabeprazole (Gastric Acid-Reducing Agent), or Rifampin (Strong CYP3A Inducer) in Healthy Subjects

This study will have three parts: Part A, Part B, and Part C. The primary purpose of Part A is to evaluate the effect of food on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part B is to evaluate the effects of rabeprazole (a gastric acid-reducing agent) on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part C is to evaluate the effects of rifampin (a strong Cytochrome P450 3A [CYP3A] inducer) on pharmacokinetics (PK) of single oral doses of E7090 in healthy participants.

Being tested
E7090, Rabeprazole 20 mg, Rifampin 600 mg
Keywords
E7090, Food-effect, Drug-drug Interactions, Rabeprazole, Rifampin

What participants receive

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

  • E7090Drug

    Oral tablet.

  • Rabeprazole 20 mgDrug

    Rabeprazole 20 mg (2 tablets, each of 10 mg) oral tablet.

  • Rifampin 600 mgDrug

    Rifampin 600 mg (4 capsules, each of 150 mg) oral capsule.

Study groups in NCT04565574
Study groupRoleWhat they receive
Part A: E7090 35 mg (Fasted + Fed + Fed)ExperimentalParticipants will receive E7090 35 milligram (mg) tablet, orally on Day 1 of Treatment Period 1 in fasted state, followed by E7090 35 mg tablet, orally on Day 1 of Treatment Period 2 in fed state (high-fat meal). A wash out period of 5 days will be maintained between Treatment Periods 1 and 2. Further participant will receive E7090 35 mg tablet, orally on Day 1 of Treatment Period 3 in fed state (low-fat meal).
Receives: Drug: E7090
Part A: E7090 35 mg (Fed + Fasted + Fed)ExperimentalParticipants will receive E7090 35 mg tablet, orally on Day 1 of Treatment Period 1 in fed state (high-fat meal), followed by E7090 35 mg tablet, orally on Day 1 of Treatment Period 2 in fasted state. A wash out period of 5 days will be maintained between Treatment Periods 1 and 2. Further participant will receive E7090 35 mg tablet, orally on Day 1 of Treatment Period 3 in fed state (low-fat meal).
Receives: Drug: E7090
Part B: E7090 35 mg + Rabeprazole 20 mgExperimentalParticipants will receive E7090 35 mg tablet, orally on Day 1 in fasted state, followed by a wash out period of 5 days, further followed by rabeprazole 20 mg tablets, orally, once daily on Days 7 to 10, and then followed by E7090 35 mg tablet and rabeprazole 20 mg tablets, orally on Day 11 in fasted state.
Receives: Drug: E7090; Drug: Rabeprazole 20 mg
Part C: E7090 35 mg + Rifampin 600 mgExperimentalParticipants will receive E7090 35 mg tablet, orally on Day 1 in fasted state, followed by a wash out period of 5 days, further followed by rifampin 600 mg capsules, orally, once daily on Days 7 to 12, then followed by E7090 35 mg tablet and rifampin 600 mg capsules, orally on Day 13 in fasted state, and then by rifampin 600 mg capsules, orally, once daily on Days 14 to 18.
Receives: Drug: E7090; Drug: Rifampin 600 mg

What is being measured

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

  1. Cmax: Maximum Observed Plasma Concentration of E7090

    Measured: 0-144 hours post-dose following E7090 administration

  2. AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of E7090

    Measured: 0-144 hours post-dose following E7090 administration

  3. AUC(0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of E7090

    Measured: 0-144 hours post-dose following E7090 administration

Secondary outcomes (6)

  1. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of E7090

    Measured: 0-144 hours post-dose following E7090 administration

  2. AUC(0-72Hours): Area Under the Plasma Concentration Versus Time Curve from Time 0 to 72 Hours of E7090

    Measured: 0-144 hours post-dose following E7090 administration

  3. T1/2: Terminal Half-life of E7090

    Measured: 0-144 hours post-dose following E7090 administration

  4. CL/F: Apparent Total Body Clearance of E7090

    Measured: 0-144 hours post-dose following E7090 administration

  5. Vz/F: Apparent Volume of Distribution at Terminal Phase of E7090

    Measured: 0-144 hours post-dose following E7090 administration

  6. AUC Metabolite (M) Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of E7090

    Measured: 0-144 hours post-dose following E7090 administration

Timeline

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

  1. First posted25 Sep 2020
  2. Study start16 Oct 2020
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04565574
Sponsor's protocol ID
E7090-J081-003
Status last verified
Oct 2021
First submitted
23 Sep 2020
Last updated
1 Nov 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/.

Publications

  • Nomoto M, Hasunuma T, Cai C, Suzuki I, Mikubo A, Funasaka S, Otake Y, Nakai K, Yasuda S. Effects of Food, Gastric Acid Reduction, and Strong CYP3A Induction on the Pharmacokinetics of Tasurgratinib, a Novel Selective Fibroblast Growth Factor Receptor Inhibitor. J Clin Pharmacol. 2024 Dec;64(12):1541-1551. doi: 10.1002/jcph.6104. Epub 2024 Aug 1.

    PubMed 39087871

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E7090, Rabeprazole 20 mg and Rifampin 600 mg in people with Healthy Participants, run by Eisai Co., Ltd. at 1 site in Japan.

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 8 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 1 Nov 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 Japan. 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 of E7090 (time frame: 0-144 hours post-dose following E7090 administration). The study lists 3 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 NCT04565574, which also lists 1 linked publication.

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 1 Nov 2021.

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