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A Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects

NCT ID: NCT02289599

Last Updated: 2016-01-18

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

2014-11-30

Study Completion Date

2015-07-31

Brief Summary

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This study will be a single-center, single dose, randomized, double-blind, placebo-controlled study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be treated with single ascending doses of E2307. The maximum tolerated dose (MTD) will be determined in Part A. Part B will be initiated after Part A is completed. In Part B one cohort of healthy elderly subjects will be treated with a single dose of E2307 at one dose level below the MTD. In part A, a total of 56 subjects will be enrolled into 7 cohorts sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized, 6 subjects to a single dose of E2307 and 2 subjects to placebo.

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Detailed Description

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Conditions

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Healthy Subjects

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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Part A: 1 mg E2307 (young cohort)

E2307 (1 x 1 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)

Group Type EXPERIMENTAL

E2307

Intervention Type DRUG

E2307 Matching Placebo

Intervention Type DRUG

Part A: 3 mg E2307 (young cohort)

E2307 (3 x 1 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)

Group Type EXPERIMENTAL

E2307

Intervention Type DRUG

E2307 Matching Placebo

Intervention Type DRUG

Part A: 10 mg E2307 (young cohort)

E2307 (1 x 10 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)

Group Type EXPERIMENTAL

E2307

Intervention Type DRUG

E2307 Matching Placebo

Intervention Type DRUG

Part A: 30 mg E2307 (young cohort)

E2307 (3 x 10 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)

Group Type EXPERIMENTAL

E2307

Intervention Type DRUG

E2307 Matching Placebo

Intervention Type DRUG

Part A: 100 mg E2307 (young cohort)

E2307 (1 x 100 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)

Group Type EXPERIMENTAL

E2307

Intervention Type DRUG

E2307 Matching Placebo

Intervention Type DRUG

Part A: 200 mg E2307 (young cohort)

E2307 (2 x 100 mg E2307 capsules) or placebo (2 x 1 E2307 matching placebo capsules)

Group Type EXPERIMENTAL

E2307

Intervention Type DRUG

E2307 Matching Placebo

Intervention Type DRUG

Part A: 300 mg E2307 (young cohort)

E2307 (3 x 100 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)

Group Type EXPERIMENTAL

E2307

Intervention Type DRUG

E2307 Matching Placebo

Intervention Type DRUG

Part B: Elderly cohort

One dose level below MTD from Part A

Group Type EXPERIMENTAL

E2307

Intervention Type DRUG

Interventions

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E2307

Intervention Type DRUG

E2307 Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Parts A and B

1. Provide written informed consent
2. Willing and able to comply with all aspects of the protocol

Part A: Young cohort
3. Non-smoking, male subjects age \>=20 years and less than 55 years old at the time of informed consent

Part B: Elderly Cohort
4. Non-smoking, male subjects age \>=65 years and less than 85 years old at the time of informed consent

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

1. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
2. Any history of abdominal surgery that may affect PK profiles of E2307 (eg. hepatectomy, nephrectomy, digestive organ resection)
3. Known history of clinically significant drug allergy (at Screening)
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kagoshima, Kagoshima-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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E2307-J081-001

Identifier Type: -

Identifier Source: org_study_id

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