A Single Intravenous Dose Study of E3112 in Japanese Heal... | NCT03014895

NCT03014895

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: Placebo	Placebo Comparator	Intravenous placebo infusion	Drug: Placebo
Cohort 1: E3112	Experimental	Intravenous E3112 infusion	Drug: E3112
Cohort 2: Placebo	Placebo Comparator	Intravenous placebo infusion	Drug: Placebo
Cohort 2: E3112	Experimental	Intravenous E3112 infusion	Drug: E3112
Cohort 3: Placebo	Placebo Comparator	Intravenous placebo infusion	Drug: Placebo
Cohort 3: E3112	Experimental	Intravenous E3112 infusion	Drug: E3112
Cohort 4: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Intravenous infusion	Cohort 1: Placebo Cohort 2: Placebo Cohort 3: Placebo Cohort 4: Placebo Cohort 5: Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak concentration (Cmax) of E3112	Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.	Days 1 to 4, 8, 14, and 28
Time to peak concentration (Tmax) of E3112	Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.	Days 1 to 4, 8, 14, and 28
Area under the curve (AUC)	AUC is the area under the curve in a plot of concentration of drug in blood plasma against time. AUC represents the total drug exposure over a defined period of time.	Days 1 to 4, 8, 14, and 28
Half-life of elimination (t1/2) of E3112	t1/2 is the time required for the concentration of the drug to reach half of its original value.	Days 1 to 4, 8, 14, and 28
Clearance of E3112	Clearance is defined as the rate of drug elimination divided by the plasma concentration of the drug.	Days 1 to 4, 8, 14, and 28
Volume of distribution (Vd) of E3112	Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.	Days 1 to 4, 8, 14, and 28

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with any serious adverse event and any non-serious adverse event	An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.

Eligibility Module

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