Clinical trial NCT02268838: Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
Official title: A Phase 1 Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: E6007
Healthy Japanese male subjects
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of E6007 as a measure of Adverse events
timeFrame: Screening and up to 17 days after last administration of drug
measure: Plasma E6007 concentration over time period - Cmax (maximum concentration)
timeFrame: Up to 15 days
measure: Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax))
timeFrame: Up to 15 days
measure: Plasma E6007 concentration over time period - AUC (0-t) (Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration)
timeFrame: Up to 15 days
measure: Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity)
timeFrame: Up to 15 days
measure: Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life)
timeFrame: Up to 15 days
measure: Plasma E6007 concentration over time period - CL/F (Apparent clearance)
timeFrame: Up to 15 days
measure: Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution)
timeFrame: Up to 15 days
measure: Plasma E6007 concentration over time period - Css,max (maximum steady state concentration)
timeFrame: Up to 15 days
measure: Plasma E6007 concentration over time period - AUC (0-tau) (AUC from time zero to time tau over a dosing interval at steady state)
timeFrame: Up to 15 days
Secondary outcomes:
measure: Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t)
timeFrame: Up to 15 days
measure: Geometric mean proportion (fed:fasted) of Cmax, AUC(0-t) and AUC(0-inf) for 200mg E6007 dose
timeFrame: Up to 5 days
measure: Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF)
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
state: Tokyo
Study officials:
References: