Clinical trial NCT03014895: A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Male Volunteers
Keywords: E3112
Pharmacokinetics
Japanese
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 29
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.


Eligibility criteria: Inclusion Criteria:

Main Inclusion Criteria:

* Non-smoking, Japanese, male participants, ≥20 and \<45 years old at the time of obtaining informed consent
* Have a Body Mass Index (BMI) ≥18.5 and \<25.0 kilograms per meters squared (kg/m\^2) at Screening
* Able to provide written informed consent of their free will
* Males who were given a full explanation of all the requirements of the protocol, and are willing and able to comply with them

Exclusion Criteria:

Main Exclusion Criteria:

* Male and his partner who do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
* Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing.
* Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
* Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of study drug at Screening
* Any suspected clinically abnormal symptom or organ impairment that require medical treatment at Screening or Baseline
* Receipt of vaccination within 4 weeks prior to dosing
* History of drug or alcohol dependency or abuse prior to Screening
* Intake of caffeinated beverages or food within 72 hours prior to dosing
* Use of prescription drugs within 4 weeks prior to dosing
* Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
* Male who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing
* Male who underwent a blood transfusion within 12 weeks prior to dosing, who donate 400 milliliters (mL) or more of whole blood within 12 weeks prior to dosing, who donate 200 mL or more of whole blood within 4 weeks prior to dosing, or who made a component donation within 2 weeks prior to dosing

Primary outcomes:
measure: Peak concentration (Cmax) of E3112
timeFrame: Days 1 to 4, 8, 14, and 28
measure: Time to peak concentration (Tmax) of E3112
timeFrame: Days 1 to 4, 8, 14, and 28
measure: Area under the curve (AUC)
timeFrame: Days 1 to 4, 8, 14, and 28
measure: Half-life of elimination (t1/2) of E3112
timeFrame: Days 1 to 4, 8, 14, and 28
measure: Clearance of E3112
timeFrame: Days 1 to 4, 8, 14, and 28
measure: Volume of distribution (Vd) of E3112
timeFrame: Days 1 to 4, 8, 14, and 28
Secondary outcomes:
measure: Number of participants with any serious adverse event and any non-serious adverse event
timeFrame: Days 1 to 28
measure: Number of participants with an abnormal, clinically significant hematology parameter value
timeFrame: Days 1 to 28
measure: Number of participants with an abnormal, clinically significant blood chemistry parameter value
timeFrame: Days 1 to 28
measure: Number of participants with an abnormal, clinically significant urine value
timeFrame: Days 1 to 28
measure: Number of participants with an abnormal, clinically significant vital sign measurement
timeFrame: Baseline; Days 1 to 28
measure: Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement
timeFrame: Baseline; Days 1 to 28
measure: Number of participants with an abnormal, clinically significant physical examination measurement
timeFrame: Baseline; Days 1 to 28
Other outcomes:
Locations:
city: Toshima
country: Japan
facility: EA Pharma Trial Site
state: Tokyo
Study officials:
References: