NCT02947711

Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy Subjects

An Open-label, Single-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This Phase 1, open-label, single-sequence, drug-drug Interaction study is conducted to evaluate the effect of diltiazem extended release (ER) (a moderate CYP3A inhibitor and P glycoprotein \[Pgp\] inhibitor) on the pharmacokinetics (PK) of a single oral dose of E2027 in healthy participants.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	E2027	2 x 50 mg capsules, once daily on Day 1 and Day 12
DRUG	Diltiazem ER	1 x 300 mg capsule, once daily on Days 7 through 24

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-11-01
• Completion: 2017-01-01
• First posted: 2016-10-28
• Last updated: 2017-03-07

Locations

1 site across 1 country: United States