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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2021-11-01
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
Interventions
- DRUG
-
E7090
Oral tablet.
- DRUG
-
Rabeprazole 20 mg
Rabeprazole 20 mg (2 tablets, each of 10 mg) oral tablet.
- DRUG
-
Rifampin 600 mg
Rifampin 600 mg (4 capsules, each of 150 mg) oral capsule.
Sponsors & Collaborators
-
Eisai Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-16
- Primary Completion
- 2021-03-31
- Completion
- 2021-03-31
Countries
- Japan
Study Locations
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