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

January 15, 2016 updated by: Eisai Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Single-Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: 1 mg E2307 (young cohort)
E2307 (1 x 1 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 3 mg E2307 (young cohort)
E2307 (3 x 1 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 10 mg E2307 (young cohort)
E2307 (1 x 10 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 30 mg E2307 (young cohort)
E2307 (3 x 10 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 100 mg E2307 (young cohort)
E2307 (1 x 100 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 200 mg E2307 (young cohort)
E2307 (2 x 100 mg E2307 capsules) or placebo (2 x 1 E2307 matching placebo capsules)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 300 mg E2307 (young cohort)
E2307 (3 x 100 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part B: Elderly cohort
One dose level below MTD from Part A
Drug: E2307

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events/serious adverse events
Time Frame: Up to 30 days
Up to 30 days
Plasma pharmacokinetics (PK) of E2307: Cmax (maximum observed concentration)
Time Frame: Up to 12 days
Up to 12 days
Plasma PK of E2307: tmax (time at which the highest drug concentration occurs)
Time Frame: Up to 12 days
Up to 12 days
Plasma PK of E2307: AUC(0-t) [area under the concentration (AUC)-time curve from zero time to time of last quantifiable concentration]
Time Frame: Up to 12 days
Up to 12 days
Plasma PK of E2307: AUC(0-inf) [area under the concentration-time curve from zero time extrapolated to infinite time]
Time Frame: Up to 12 days
Up to 12 days
Plasma PK of E2307: t1/2 (terminal elimination phase half-life)
Time Frame: Up to 12 days
Up to 12 days
Plasma PK of E2307: CL/F (apparent total clearance following oral administration)
Time Frame: Up to 12 days
CL/F are calculated for E2307 only
Up to 12 days
Plasma PK of E2307: Vz/F (apparent volume of distribution at terminal phase)
Time Frame: Up to 12 days
Vz/F are calculated for E2307 only
Up to 12 days
Plasma PK of E2307: AUC ratio (AUC ratio of metabolite to parent)
Time Frame: Up to 12 days
Up to 12 days
Urine PK of E2307: Ae (cumulative amount of drug excreted in urine up to 264 hours postdose)
Time Frame: Up to 12 days
Up to 12 days
Urine PK of E2307: CLR (renal clearance)
Time Frame: Up to 12 days
Up to 12 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean difference in change of mean blood pressure (BP) between E2307 and placebo
Time Frame: 24 hours predose and continue until 24 hours postdose (Day 2)
24 hours predose and continue until 24 hours postdose (Day 2)
QT interval assessment using Holter monitoring
Time Frame: 24 hours predose through Day 2 (at 24 hours postdose)
24 hours predose through Day 2 (at 24 hours postdose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E2307-J081-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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