Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects

January 19, 2016 updated by: Eisai Co., Ltd.

A Phase 1 Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects

This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and 400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single dose of the study drug under fasted condition. Following 3 days of washout period, subject will receive the study drug once daily for 7 days starting on the fifth day from the single dose administration.

For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed condition, to evaluate food effect of the study drug.

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

  • Japan
    • Tokyo
      • Sumida-ku, Tokyo, Japan

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 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria

Subjects must meet all of the following criteria to be included in this study:

  1. Healthy Japanese male subjects aged 20 to 44 years at the time of informed consent.
  2. Has voluntarily consented, in writing, to participate in this study.
  3. Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.

Exclusion criteria

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

  1. Has a clinically significant medical condition requiring treatment within 8 weeks before the initial study drug administration, or a history of clinically significant infection requiring treatment within 4 weeks before the initial drug administration.
  2. History of surgical treatment such as resection of the liver, kidney, or Gastrointestinal tract, that may affect the Pharmacokinetic profiles of study drugs.
  3. Ineligible for study participation in the opinion of the investigator or sub-investigator.

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: 50 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 1, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
Drug: E6007
Drug: E6007 matching placebo
Experimental: 100 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 2, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
Drug: E6007
Drug: E6007 matching placebo
Experimental: 200 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
Drug: E6007
Drug: E6007 matching placebo
Experimental: 400 mg E6007 fasted condition
E6007 50mg or E6007 matching placebo x 8, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.
Drug: E6007
Drug: E6007 matching placebo
Experimental: 200 mg E6007 fed condition
E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fed condition. Drug administration on 1 day (Day 1).
Drug: E6007
Drug: E6007 matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of E6007 as a measure of Adverse events
Time Frame: Screening and up to 17 days after last administration of drug
Screening and up to 17 days after last administration of drug
Plasma E6007 concentration over time period - Cmax (maximum concentration)
Time Frame: Up to 15 days
Up to 15 days
Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax))
Time Frame: Up to 15 days
Up to 15 days
Plasma E6007 concentration over time period - AUC (0-t) (Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration)
Time Frame: Up to 15 days
Up to 15 days
Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity)
Time Frame: Up to 15 days
Up to 15 days
Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life)
Time Frame: Up to 15 days
Up to 15 days
Plasma E6007 concentration over time period - CL/F (Apparent clearance)
Time Frame: Up to 15 days
Up to 15 days
Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution)
Time Frame: Up to 15 days
Up to 15 days
Plasma E6007 concentration over time period - Css,max (maximum steady state concentration)
Time Frame: Up to 15 days
Up to 15 days
Plasma E6007 concentration over time period - AUC (0-tau) (AUC from time zero to time tau over a dosing interval at steady state)
Time Frame: Up to 15 days
Up to 15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t)
Time Frame: Up to 15 days
Up to 15 days
Geometric mean proportion (fed:fasted) of Cmax, AUC(0-t) and AUC(0-inf) for 200mg E6007 dose
Time Frame: Up to 5 days
Up to 5 days
Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF)
Time Frame: Up to 15 days
Up to 15 days

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

October 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E6007-J081-002

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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