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

Eisai Co., Ltd.24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: MALEMin age: 20 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety and tolerability of E6007 as a measure of Adverse events

Time frame: 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

Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax))

Time frame: 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

Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity)

Time frame: Up to 15 days

Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life)

Time frame: Up to 15 days

Plasma E6007 concentration over time period - CL/F (Apparent clearance)

Time frame: Up to 15 days

Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution)

Time frame: Up to 15 days

Plasma E6007 concentration over time period - Css,max (maximum steady state concentration)

Time frame: 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

Secondary Outcomes

Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t)

Time frame: 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

Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF)

Time frame: Up to 15 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes