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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565574
• Other study ID #: E7090-J081-003
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: October 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

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 Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

1. Following ocular disorders

1. Current evidence of Grade 2 or higher corneal disorder

2. Current evidence of active macular disorder (example, age-related macular degeneration, central serous chorioretinal disease)

2. 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

3. A prolonged QT/QTc interval (QT interval with Fridericia's correction [QTcF] greater than [>] 480 millisecond [ms]) demonstrated on ECG at screening or baseline

4. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at screening

5. Known history of allergies or reactions to rabeprazole or rifampin or known anaphylactic reaction to any drugs at screening

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• E7090
Oral tablet.
• Rabeprazole 20 mg
Rabeprazole 20 mg (2 tablets, each of 10 mg) oral tablet.
• Rifampin 600 mg
Rifampin 600 mg (4 capsules, each of 150 mg) oral capsule.

Locations

Country	Name	City	State
Japan	Eisai trial site #1	Minato-ku	Tokoyo

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration of E7090		0-144 hours post-dose following E7090 administration
Primary	AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of E7090		0-144 hours post-dose following E7090 administration
Primary	AUC(0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of E7090		0-144 hours post-dose following E7090 administration
Secondary	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of E7090		0-144 hours post-dose following E7090 administration
Secondary	AUC(0-72Hours): Area Under the Plasma Concentration Versus Time Curve from Time 0 to 72 Hours of E7090		0-144 hours post-dose following E7090 administration
Secondary	T1/2: Terminal Half-life of E7090		0-144 hours post-dose following E7090 administration
Secondary	CL/F: Apparent Total Body Clearance of E7090		0-144 hours post-dose following E7090 administration
Secondary	Vz/F: Apparent Volume of Distribution at Terminal Phase of E7090		0-144 hours post-dose following E7090 administration
Secondary	AUC Metabolite (M) Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of E7090		0-144 hours post-dose following E7090 administration