A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants
- Registration Number
- NCT03922633
- Lead Sponsor
- EA Pharma Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Non-smoking Japanese males aged 20 to 44 years at the time of written, informed consent
- Body Mass Index (BMI) at screening is 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2)
- Written, informed consent to participate in the study based on the participant's own free will
- Willing and able to comply with the requirements in the study after being fully informed of the requirements
Exclusion Criteria
- Male participants with reproductive potential who and whose partner do not agree to practice medically appropriate contraception (Note: throughout the study)
- A history or complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disorder, a clinically significant disease requiring treatments within 8 weeks before the investigational product treatment, or a history of a clinically significant infection within 4 weeks before the investigational product treatment
- With a psychiatric, digestive, hepatic, renal, respiratory, endocrine, hematologic, neural, or cardiovascular disease within 4 weeks before the investigational product treatment, a congenital metabolic abnormality, or otherwise a disease that may affect the drug assessments
- With a surgical history (e.g., resection of the liver, kidney, or digestive tract, etc.) at screening that may affect the pharmacokinetics of the investigational product
- Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
- Testing positive for human immunodeficiency virus (HIV) at screening
- A positive response to a qualitative test for hepatitis B virus surface antigen (HBs antigen), hepatitis B virus core antigen (HBc) antibody, hepatitis C virus (HCV) antibody, or syphilis
- Use of a prescription drug within 4 weeks before the investigational product treatment
- Use of an over-the-counter drug within 2 weeks before the investigational product treatment
- Receiving a vaccine within 4 weeks before the investigational product treatment
- Ongoing participation in another clinical study or use of an investigational product or device within 16 weeks before the investigational product treatment while participating in another clinical study
- Receiving blood transfusion within 12 weeks before the investigational product treatment, providing a whole-blood sample of 400 millilitre (mL) or more between 12 to 4 weeks before the investigational product treatment or a whole-blood sample of 200 mL or more within 4 weeks before the investigational product treatment, or giving blood components by pheresis within 2 weeks before the investigational product treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 Group A: E3112 + Placebo E3112 E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 1 Group A: E3112 + Placebo Placebo E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 2 Group A: E3112 + Placebo Placebo E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 1 Group B: Placebo + E3112 Placebo Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 2 Group B: Placebo + E3112 E3112 Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 2 Group B: Placebo + E3112 Placebo Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 3 Group A: E3112 + Placebo Placebo E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 3 Group B: Placebo + E3112 Placebo Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 4 Group A: E3112 + Placebo Placebo E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 4 Group B: Placebo + E3112 Placebo Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 1 Group B: Placebo + E3112 E3112 Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 2 Group A: E3112 + Placebo E3112 E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 3 Group A: E3112 + Placebo E3112 E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 3 Group B: Placebo + E3112 E3112 Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 4 Group A: E3112 + Placebo E3112 E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Cohort 4 Group B: Placebo + E3112 E3112 Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
- Primary Outcome Measures
Name Time Method Serum Concentrations of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours Change from Baseline in Serum Concentration of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours Peak Concentration (Cmax) of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours 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.
Time to Peak Concentration (Tmax) of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours 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.
Area Under the Concentration-time Curve (AUC 0-t) of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.
Area Under the Concentration-time Curve (AUC∞) of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.
Half-life of Elimination (t1/2) of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours t1/2 is the time required for the concentration of the drug to reach half of its original value.
Clearance (CL) of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours CL is defined as the rate of drug elimination divided by the plasma concentration of the drug.
Volume of Distribution (Vd) of E3112 Day 1: 0-24 hours; Day 8: 0-24 hours 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.
- Secondary Outcome Measures
Name Time Method Number of Participants with an Abnormal, Clinically Significant Hematology parameter value Day 1 to Day 43 Number of Participants with Clinically Significant Change in Electrocardiogram (ECG) Day 1 to Day 43 Number of Participants with Clinically Significant Change in Physical Findings Day 1 to Day 43 Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Day 1 to Day 43 Number of Participants with an Abnormal, Clinically Significant Urine Value Day 1 to Day 43 Number of Participants with Clinically Significant Change in Vital Signs Day 1 to Day 43 Number of Participants with Clinically Significant Change in Ophthalmological Findings Day 1 to Day 43 Percentage of Participants with Serum Anti-E3112 Antibodies Day 1 to Day 43 Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value Day 1 to Day 43
Trial Locations
- Locations (1)
EA Pharma Trial Site
🇯🇵Higashi, Fukuoka, Japan