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

NCT02947711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-03-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2016-11-30
Completion
2017-01-31

Countries

  • United States

Study Locations

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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 NCT02947711 on ClinicalTrials.gov