Healthy Participants
Conditions
Keywords
E7090, Food-effect, Drug-drug Interactions, Rabeprazole, Rifampin
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.
Interventions
DRUGE7090
Oral tablet.
Rabeprazole 20 mg (2 tablets, each of 10 mg) oral tablet.
DRUGRifampin 600 mg
Rifampin 600 mg (4 capsules, each of 150 mg) oral capsule.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| CL/F: Apparent Total Body Clearance of E7090 | 0-144 hours post-dose following E7090 administration |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) 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 |
| Vz/F: Apparent Volume of Distribution at Terminal Phase 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 |
Countries
Japan
Outcome results
None listed