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

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Rabeprazole; Rifampin

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