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

NCT ID: NCT04565574

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2021-03-31

Brief 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.

Conditions

Healthy Participants

Keywords

E7090; Food-effect; Drug-drug Interactions; Rabeprazole; Rifampin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: E7090 35 mg (Fasted + Fed + Fed)

Participants 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).

Group Type: EXPERIMENTAL

E7090

Intervention Type: DRUG

Oral tablet.

Part A: E7090 35 mg (Fed + Fasted + Fed)

Participants 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).

Group Type: EXPERIMENTAL

E7090

Intervention Type: DRUG

Oral tablet.

Part B: E7090 35 mg + Rabeprazole 20 mg

Participants 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.

Group Type: EXPERIMENTAL

E7090

Intervention Type: DRUG

Oral tablet.

Rabeprazole 20 mg

Intervention Type: DRUG

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

Part C: E7090 35 mg + Rifampin 600 mg

Participants 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.

Group Type: EXPERIMENTAL

E7090

Intervention Type: DRUG

Oral tablet.

Rifampin 600 mg

Intervention Type: DRUG

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

Interventions

E7090

Oral tablet.

Intervention Type: DRUG

Rabeprazole 20 mg

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

Intervention Type: DRUG

Rifampin 600 mg

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eisai trial site #1

Minatoku, Tokoyo, Japan

Countries

Japan

Other Identifiers

E7090-J081-003

Identifier Type: -

Identifier Source: org_study_id