NCT01261156

A Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy Subjects

An Open-label, Single-Sequence Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.

Detailed description

This is an open-label, 2-arm study to evaluate the effects of diltiazem given in conjunction with E5555 on the PK of diltiazem and its metabolites. This is a Phase 1 study of 24 healthy male and female subjects that will be conducted at a single site. The planned duration of treatment for each subject is approximately 15 days including 1 day in Treatment Period 1 and 14 days in Treatment Period 2.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	E5555 100 mg and diltiazem	E5555 single 100 mg oral dose in Treatment Period 1 Day 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.
DRUG	E5555 300 mg and diltiazem	E5555 single 300 mg oral dose in Treatment Period 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-12-01
• First posted: 2010-12-16
• Last updated: 2014-07-11

Locations

1 site across 1 country: Netherlands