A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects
- Registration Number
- NCT02146261
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.
- Detailed Description
This study consists of Screening Period, Observation Period, In-patient Period, and Follow-up Period. Screening assessments will be performed within 28 to 2 days before starting the study treatment, and Observation Period assessments will be performed on a day before starting the study treatment to confirm the eligibility of study subjects. The eligible subjects will be randomized into either E6011 arm or placebo arm using the drug allocation list prepared by the random code statistician. Each subjects dosing interval will be at least a 30-minutes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 E6011 Subcutaneous administration of E6011 100 mg 5 Placebo Subcutaneous administration of placebo 1 E6011 Subcutaneous administration of E6011 50 mg 3 E6011 Subcutaneous administration of E6011 200 mg 4 E6011 Subcutaneous administration of E6011 400 mg
- Primary Outcome Measures
Name Time Method Pharmacokinetics of E6011: Time to attain Cmax (tmax) Up to 10 Weeks Pharmacokinetics of E6011: Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-t) Up to 10 Weeks Pharmacokinetics of E6011: Elimination half-life (t1/2) Up to 10 Weeks Safety and Tolerability of E6011 Up to 10 Weeks The safety will be assessed based on all adverse events (AEs), clinical laboratory test, vital signs, body weight, physical finding, administration site finding, electrocardiography and chest xray.
Pharmacokinetics of E6011: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time AUC(0-inf) Up to 10 Weeks Pharmacokinetics of E6011: CL/F Up to 10 Weeks Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-?).
Pharmacokinetics of E6011: Apparent Volume of Distribution of Azacitidine (Vz/F) Up to 10 Weeks Pharmacokinetics of E6011: Maximum Concentration (Cmax) Up to 10 Weeks
- Secondary Outcome Measures
Name Time Method