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2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects

NCT ID: NCT01673451

Last Updated: 2013-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-07-31

Brief Summary

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This is a single-center, randomized, double-blind, placebo-controlled, sequential, multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening dosing).

Detailed Description

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Conditions

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CNS

Keywords

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insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules

E2006

Group Type EXPERIMENTAL

E2006

Intervention Type DRUG

Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules

Interventions

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E2006

Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules

Intervention Type DRUG

Placebo comparator

E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Performed shift work within 2 weeks prior to Screening
* Had taken a flight across three or more time zones in the 7 days prior to Screening
* Female subjects who are nursing
* With a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profile of E2006
* With a known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
* Hypersensitivity to the study drug or any of the excipients
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dohwa Kim

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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Parexel, California Clinical Trials

Culver City, California, United States

Site Status

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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E2006-A001-002

Identifier Type: -

Identifier Source: org_study_id