A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants

Healthy Male Participants Clinical Trial

Official title:

A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922633
• Other study ID #: E3112-CP2
• Status: Completed
• Phase: Phase 1
• Start date: April 22, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: March 2020
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 1, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Participants

Intervention

Drug:
• E3112
Intravenous infusion.

Other:
• Placebo
Intravenous infusion.

Locations

Country	Name	City	State
Japan	EA Pharma Trial Site	Higashi	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
EA Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Concentrations of E3112		Day 1: 0-24 hours; Day 8: 0-24 hours
Primary	Change from Baseline in Serum Concentration of E3112		Day 1: 0-24 hours; Day 8: 0-24 hours
Primary	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.	Day 1: 0-24 hours; Day 8: 0-24 hours
Primary	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.	Day 1: 0-24 hours; Day 8: 0-24 hours
Primary	Area Under the Concentration-time Curve (AUC 0-t) of E3112	AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.	Day 1: 0-24 hours; Day 8: 0-24 hours
Primary	Area Under the Concentration-time Curve (AUC8) of E3112	AUC8 is area under the concentration-time curve from time 0 to infinity of E3112.	Day 1: 0-24 hours; Day 8: 0-24 hours
Primary	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.	Day 1: 0-24 hours; Day 8: 0-24 hours
Primary	Clearance (CL) of E3112	CL is defined as the rate of drug elimination divided by the plasma concentration of the drug.	Day 1: 0-24 hours; Day 8: 0-24 hours
Primary	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.	Day 1: 0-24 hours; Day 8: 0-24 hours
Secondary	Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Day 1 to Day 43
Secondary	Number of Participants with an Abnormal, Clinically Significant Hematology parameter value		Day 1 to Day 43
Secondary	Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value		Day 1 to Day 43
Secondary	Number of Participants with an Abnormal, Clinically Significant Urine Value		Day 1 to Day 43
Secondary	Number of Participants with Clinically Significant Change in Vital Signs		Day 1 to Day 43
Secondary	Number of Participants with Clinically Significant Change in Electrocardiogram (ECG)		Day 1 to Day 43
Secondary	Number of Participants with Clinically Significant Change in Physical Findings		Day 1 to Day 43
Secondary	Number of Participants with Clinically Significant Change in Ophthalmological Findings		Day 1 to Day 43
Secondary	Percentage of Participants with Serum Anti-E3112 Antibodies		Day 1 to Day 43