NCT01437384

Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.

An Open-label, Single-sequence, Four-treatment Period Study to Evaluate Pharmacokinetic and Pharmacodynamic Interactions Between E5501 and Verapamil, and E5501 and Cyclosporine, Known P-glycoprotein Inhibitors in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment phase will include screening and baseline period 1. The treatment phase consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose; Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each treatment period. The screening period will be up to 13 days in duration. After fulfilling screening requirements, subjects will check into the clinic on Day -1 for baseline assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient visits. They will be domiciled in the clinical testing facility for at least 14 days for Treatment Period 2 and will return intermittently for study procedures for 7 outpatient visits.

Conditions

• Idiopathic Thrombocytopenic Purpura (ITP)

Interventions

Type	Name	Description
DRUG	E5501	20 mg oral dose of E5501; 240 mg once daily oral dose of sustained release verapamil; 400 mg oral dose of cyclosporine

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-03-01
• First posted: 2011-09-20
• Last updated: 2012-05-21

Locations

1 site across 1 country: United States