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Completed

NCT Number: NCT04565574

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

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.

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Key information

Conditions

Healthy Participants

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eisai trial site #1

Minatoku, Tokoyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants who meet all of the following criteria will be eligible for participation in the study

  • Body mass index (BMI) between 18.5 to 25.0 kilogram per square meter (kg/m^2), inclusive, at screening

Exclusion criteria

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

Treatment and study plan

E7090

Drug

Oral tablet.

Rabeprazole 20 mg

Drug

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

rifampin 600 mg

Drug

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

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration of E7090

    Time frame: 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

    Time frame: 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

    Time frame: 0-144 hours post-dose following E7090 administration

Secondary outcomes

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

    Time frame: 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

    Time frame: 0-144 hours post-dose following E7090 administration

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

    Time frame: 0-144 hours post-dose following E7090 administration

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

    Time frame: 0-144 hours post-dose following E7090 administration

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

    Time frame: 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

    Time frame: 0-144 hours post-dose following E7090 administration

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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