Clinical trial NCT04565574: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: E7090
Food-effect
Drug-drug Interactions
Rabeprazole
Rifampin
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
measure: AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
measure: AUC(0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
Secondary outcomes:
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
measure: AUC(0-72Hours): Area Under the Plasma Concentration Versus Time Curve from Time 0 to 72 Hours of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
measure: T1/2: Terminal Half-life of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
measure: CL/F: Apparent Total Body Clearance of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
measure: Vz/F: Apparent Volume of Distribution at Terminal Phase of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
measure: AUC Metabolite (M) Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of E7090
timeFrame: 0-144 hours post-dose following E7090 administration
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Eisai trial site #1
state: Tokoyo
Study officials:
References: