A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03014895
• Date of registration: 06/01/2017
• Prospective Registration: Yes
• Primary sponsor: EA Pharma Co., Ltd.
• Public title: A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects
• Date of first enrolment: January 25, 2017
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03014895
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Early Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 44 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Male Volunteers

Intervention(s)

Drug: Placebo

Drug: E3112

Primary Outcome(s)

Half-life of elimination (t1/2) of E3112 [Time Frame: Days 1 to 4, 8, 14, and 28]

Peak concentration (Cmax) of E3112 [Time Frame: Days 1 to 4, 8, 14, and 28]

Area under the curve (AUC) [Time Frame: Days 1 to 4, 8, 14, and 28]

Volume of distribution (Vd) of E3112 [Time Frame: Days 1 to 4, 8, 14, and 28]

Clearance of E3112 [Time Frame: Days 1 to 4, 8, 14, and 28]

Time to peak concentration (Tmax) of E3112 [Time Frame: Days 1 to 4, 8, 14, and 28]

Secondary Outcome(s)

Number of participants with an abnormal, clinically significant hematology parameter value [Time Frame: Days 1 to 28]

Number of participants with an abnormal, clinically significant blood chemistry parameter value [Time Frame: Days 1 to 28]

Number of participants with an abnormal, clinically significant physical examination measurement [Time Frame: Baseline; Days 1 to 28]

Number of participants with an abnormal, clinically significant urine value [Time Frame: Days 1 to 28]

Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement [Time Frame: Baseline; Days 1 to 28]

Number of participants with an abnormal, clinically significant vital sign measurement [Time Frame: Baseline; Days 1 to 28]

Number of participants with any serious adverse event and any non-serious adverse event [Time Frame: Days 1 to 28]

Secondary ID(s)

E3112/CP1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors