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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: E5555 300 mg and diltiazem; Drug: E5555 100 mg and diltiazem

• Registration Number: NCT01261156
• Lead Sponsor: Eisai Inc.

Brief 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-16
• Primary Completion: 2010-12
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-16
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study Arm 2	E5555 300 mg and diltiazem	-
Study Arm 1	E5555 100 mg and diltiazem	-

Primary Outcome Measures

Name	Time	Method
Evaluate the effects of diltiazem on the pharmacokinetics (PK ie. Cmax, Tmax, AUC and half-life) of E5555 and its known metabolites.	18 days
Evaluate the effects of diltiazem on the thrombin- and thrombin receptor activating peptide (TRAP) -induced platelet aggregation of E5555 and its known metabolites	18 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of co-adminstration of diltiazem and E5555 on the PK(ie. Cmax, Tmax, AUC and half-life) of diltiazem and its metabolites	18 days
To assess safety and tolerability of a single dose of E5555 when given alone or in combination with diltiazem by recording the number of all adverse events following drug administration	18 days
To evaluate effects of co-adminstration of diltiazem and E5555 on QTcF compared to E5555 alone	18 days

Trial Locations

Locations (1)

PRA International; 🇳🇱 Zuidlaren, Netherlands