Clinical trial NCT03922633: A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants
Official title: A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Participants
Keywords: E3112
Phase 1
Pharmacokinetics
Japanese
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. Non-smoking Japanese males aged 20 to 44 years at the time of written, informed consent
2. Body Mass Index (BMI) at screening is 18.5 or more but less than 25.0 kilogram per square metre (kg/m\^2)
3. Written, informed consent to participate in the study based on the participant's own free will
4. Willing and able to comply with the requirements in the study after being fully informed of the requirements

Exclusion Criteria:

1. Male participants with reproductive potential who and whose partner do not agree to practice medically appropriate contraception (Note: throughout the study)
2. 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
3. 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
4. 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
5. 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
6. Testing positive for human immunodeficiency virus (HIV) at screening
7. 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
8. Use of a prescription drug within 4 weeks before the investigational product treatment
9. Use of an over-the-counter drug within 2 weeks before the investigational product treatment
10. Receiving a vaccine within 4 weeks before the investigational product treatment
11. 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
12. 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

Primary outcomes:
measure: Serum Concentrations of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
measure: Change from Baseline in Serum Concentration of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
measure: Peak Concentration (Cmax) of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
measure: Time to Peak Concentration (Tmax) of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
measure: Area Under the Concentration-time Curve (AUC 0-t) of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
measure: Area Under the Concentration-time Curve (AUC∞) of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
measure: Half-life of Elimination (t1/2) of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
measure: Clearance (CL) of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
measure: Volume of Distribution (Vd) of E3112
timeFrame: Day 1: 0-24 hours; Day 8: 0-24 hours
Secondary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 to Day 43
measure: Number of Participants with an Abnormal, Clinically Significant Hematology parameter value
timeFrame: Day 1 to Day 43
measure: Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value
timeFrame: Day 1 to Day 43
measure: Number of Participants with an Abnormal, Clinically Significant Urine Value
timeFrame: Day 1 to Day 43
measure: Number of Participants with Clinically Significant Change in Vital Signs
timeFrame: Day 1 to Day 43
measure: Number of Participants with Clinically Significant Change in Electrocardiogram (ECG)
timeFrame: Day 1 to Day 43
measure: Number of Participants with Clinically Significant Change in Physical Findings
timeFrame: Day 1 to Day 43
measure: Number of Participants with Clinically Significant Change in Ophthalmological Findings
timeFrame: Day 1 to Day 43
measure: Percentage of Participants with Serum Anti-E3112 Antibodies
timeFrame: Day 1 to Day 43
Other outcomes:
Locations:
city: Higashi
country: Japan
facility: EA Pharma Trial Site
state: Fukuoka
Study officials:
References: