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A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy Subjects

NCT02873156 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2018-09-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.

Conditions

  • Healthy Subjects

Interventions

DRUG

E2027

Participants will receive E2027 capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 will be administered orally with 240 milliliter (mL) (8 fluid ounces) of water.

DRUG

E2027 matched placebo

Participants will receive E2027 matched placebo capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 matched placebo will be administered orally with 240 mL (8 fluid ounces) of water.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-10
Primary Completion
2017-11-29
Completion
2017-11-29
FDA Drug
Yes

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 NCT02873156 on ClinicalTrials.gov