MedTrace Logo

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

NCT01261156 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-07-11

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Chukwuemeka Okereke · Eisai Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01261156 on ClinicalTrials.gov