Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
- Registration Number
- NCT02268838
- Lead Sponsor
- Eisai Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 mg E6007 fasted condition E6007 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. 50 mg E6007 fasted condition E6007 matching placebo 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. 100 mg E6007 fasted condition E6007 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. 100 mg E6007 fasted condition E6007 matching placebo 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. 200 mg E6007 fasted condition E6007 matching placebo 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. 400 mg E6007 fasted condition E6007 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. 400 mg E6007 fasted condition E6007 matching placebo 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. 200 mg E6007 fed condition E6007 E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fed condition. Drug administration on 1 day (Day 1). 200 mg E6007 fed condition E6007 matching placebo E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fed condition. Drug administration on 1 day (Day 1). 200 mg E6007 fasted condition E6007 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.
- Primary Outcome Measures
Name Time Method Plasma E6007 concentration over time period - Cmax (maximum concentration) 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) Up to 15 days Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution) Up to 15 days Plasma E6007 concentration over time period - Css,max (maximum steady state concentration) Up to 15 days Safety and tolerability of E6007 as a measure of Adverse events Screening and up to 17 days after last administration of drug Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax)) 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) Up to 15 days Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity) Up to 15 days Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life) Up to 15 days Plasma E6007 concentration over time period - CL/F (Apparent clearance) Up to 15 days
- Secondary Outcome Measures
Name Time Method Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t) Up to 15 days Geometric mean proportion (fed:fasted) of Cmax, AUC(0-t) and AUC(0-inf) for 200mg E6007 dose Up to 5 days Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF) Up to 15 days