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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268838
• Other study ID #: E6007-J081-002
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2014
• Last updated: January 19, 2016
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• E6007

• E6007 matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of E6007 as a measure of Adverse events		Screening and up to 17 days after last administration of drug	Yes
Primary	Plasma E6007 concentration over time period - Cmax (maximum concentration)		Up to 15 days	No
Primary	Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax))		Up to 15 days	No
Primary	Plasma E6007 concentration over time period - AUC (0-t) (Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration)		Up to 15 days	No
Primary	Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity)		Up to 15 days	No
Primary	Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life)		Up to 15 days	No
Primary	Plasma E6007 concentration over time period - CL/F (Apparent clearance)		Up to 15 days	No
Primary	Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution)		Up to 15 days	No
Primary	Plasma E6007 concentration over time period - Css,max (maximum steady state concentration)		Up to 15 days	No
Primary	Plasma E6007 concentration over time period - AUC (0-tau) (AUC from time zero to time tau over a dosing interval at steady state)		Up to 15 days	No
Secondary	Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t)		Up to 15 days	No
Secondary	Geometric mean proportion (fed:fasted) of Cmax, AUC(0-t) and AUC(0-inf) for 200mg E6007 dose		Up to 5 days	No
Secondary	Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF)		Up to 15 days	No