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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-10-16
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2020-09-25
• Last updated: 2021-11-01

Locations

1 site across 1 country: Japan