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

Sponsor

Eisai Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04565574

Collaborator

(none)

Enrollment

Location

Arms

5.5

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: E7090 Drug: Rabeprazole 20 mg Drug: Rifampin 600 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 16, 2020

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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