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

NCT04565574 | Completed Phase 1

• 1 other identifier: E7090-J081-003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration of E7090

  0-144 hours post-dose following E7090 administration

• 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

• 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 Outcomes (6)

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

  0-144 hours post-dose following E7090 administration

• 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

• T1/2: Terminal Half-life of E7090

  0-144 hours post-dose following E7090 administration

• CL/F: Apparent Total Body Clearance of E7090

  0-144 hours post-dose following E7090 administration

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

  0-144 hours post-dose following E7090 administration

Study Arms (4)

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

EXPERIMENTAL

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).

Drug: E7090

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

EXPERIMENTAL

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).

Drug: E7090

Part B: E7090 35 mg + Rabeprazole 20 mg

EXPERIMENTAL

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.

Drug: E7090; Drug: Rabeprazole 20 mg

Part C: E7090 35 mg + Rifampin 600 mg

EXPERIMENTAL

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.

Drug: E7090; Drug: Rifampin 600 mg

Interventions

E7090 DRUG

Oral tablet.

Part A: E7090 35 mg (Fasted + Fed + Fed); Part A: E7090 35 mg (Fed + Fasted + Fed); Part B: E7090 35 mg + Rabeprazole 20 mg; Part C: E7090 35 mg + Rifampin 600 mg

Rabeprazole 20 mg DRUG

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

Part B: E7090 35 mg + Rabeprazole 20 mg

Rifampin 600 mg DRUG

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

Part C: E7090 35 mg + Rifampin 600 mg

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Eisai trial site #1

Minatoku, Tokoyo, Japan

Location

MeSH Terms

Interventions

Rabeprazole; Rifampin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 25, 2020
• Study Start: October 16, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)