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出境医 / 临床实验 / A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Male Participants Drug: E3112 Other: Placebo Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects
Actual Study Start Date : April 22, 2019
Actual Primary Completion Date : May 20, 2020
Actual Study Completion Date : October 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Cohort 1 Group A: E3112 + 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.
Drug: E3112
Intravenous infusion.

Other: Placebo
Intravenous infusion.

Experimental: Cohort 1 Group B: Placebo + 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.
Drug: E3112
Intravenous infusion.

Other: Placebo
Intravenous infusion.

Experimental: Cohort 2 Group A: E3112 + 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.
Drug: E3112
Intravenous infusion.

Other: Placebo
Intravenous infusion.

Experimental: Cohort 2 Group B: Placebo + 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.
Drug: E3112
Intravenous infusion.

Other: Placebo
Intravenous infusion.

Experimental: Cohort 3 Group A: E3112 + 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.
Drug: E3112
Intravenous infusion.

Other: Placebo
Intravenous infusion.

Experimental: Cohort 3 Group B: Placebo + 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.
Drug: E3112
Intravenous infusion.

Other: Placebo
Intravenous infusion.

Experimental: Cohort 4 Group A: E3112 + 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.
Drug: E3112
Intravenous infusion.

Other: Placebo
Intravenous infusion.

Experimental: Cohort 4 Group B: Placebo + 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.
Drug: E3112
Intravenous infusion.

Other: Placebo
Intravenous infusion.

Outcome Measures
Primary Outcome Measures :
  1. Serum Concentrations of E3112 [ Time Frame: Day 1: 0-24 hours; Day 8: 0-24 hours ]
  2. Change from Baseline in Serum Concentration of E3112 [ Time Frame: Day 1: 0-24 hours; Day 8: 0-24 hours ]
  3. Peak Concentration (Cmax) of E3112 [ Time Frame: 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.

  4. Time to Peak Concentration (Tmax) of E3112 [ Time Frame: 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.

  5. Area Under the Concentration-time Curve (AUC 0-t) of E3112 [ Time Frame: 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.

  6. Area Under the Concentration-time Curve (AUC∞) of E3112 [ Time Frame: 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.

  7. Half-life of Elimination (t1/2) of E3112 [ Time Frame: 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.

  8. Clearance (CL) of E3112 [ Time Frame: 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.

  9. Volume of Distribution (Vd) of E3112 [ Time Frame: 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 :
  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 to Day 43 ]
  2. Number of Participants with an Abnormal, Clinically Significant Hematology parameter value [ Time Frame: Day 1 to Day 43 ]
  3. Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value [ Time Frame: Day 1 to Day 43 ]
  4. Number of Participants with an Abnormal, Clinically Significant Urine Value [ Time Frame: Day 1 to Day 43 ]
  5. Number of Participants with Clinically Significant Change in Vital Signs [ Time Frame: Day 1 to Day 43 ]
  6. Number of Participants with Clinically Significant Change in Electrocardiogram (ECG) [ Time Frame: Day 1 to Day 43 ]
  7. Number of Participants with Clinically Significant Change in Physical Findings [ Time Frame: Day 1 to Day 43 ]
  8. Number of Participants with Clinically Significant Change in Ophthalmological Findings [ Time Frame: Day 1 to Day 43 ]
  9. Percentage of Participants with Serum Anti-E3112 Antibodies [ Time Frame: Day 1 to Day 43 ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Japan
EA Pharma Trial Site
Higashi, Fukuoka, Japan
Sponsors and Collaborators
EA Pharma Co., Ltd.
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date March 15, 2021
Actual Study Start Date  ICMJE April 22, 2019
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Serum Concentrations of E3112 [ Time Frame: Day 1: 0-24 hours; Day 8: 0-24 hours ]
  • Change from Baseline in Serum Concentration of E3112 [ Time Frame: Day 1: 0-24 hours; Day 8: 0-24 hours ]
  • Peak Concentration (Cmax) of E3112 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 to Day 43 ]
  • Number of Participants with an Abnormal, Clinically Significant Hematology parameter value [ Time Frame: Day 1 to Day 43 ]
  • Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value [ Time Frame: Day 1 to Day 43 ]
  • Number of Participants with an Abnormal, Clinically Significant Urine Value [ Time Frame: Day 1 to Day 43 ]
  • Number of Participants with Clinically Significant Change in Vital Signs [ Time Frame: Day 1 to Day 43 ]
  • Number of Participants with Clinically Significant Change in Electrocardiogram (ECG) [ Time Frame: Day 1 to Day 43 ]
  • Number of Participants with Clinically Significant Change in Physical Findings [ Time Frame: Day 1 to Day 43 ]
  • Number of Participants with Clinically Significant Change in Ophthalmological Findings [ Time Frame: Day 1 to Day 43 ]
  • Percentage of Participants with Serum Anti-E3112 Antibodies [ Time Frame: Day 1 to Day 43 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants
Official Title  ICMJE A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Male Participants
Intervention  ICMJE
  • Drug: E3112
    Intravenous infusion.
  • Other: Placebo
    Intravenous infusion.
Study Arms  ICMJE
  • Experimental: Cohort 1 Group A: E3112 + 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.
    Interventions:
    • Drug: E3112
    • Other: Placebo
  • Experimental: Cohort 1 Group B: Placebo + 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.
    Interventions:
    • Drug: E3112
    • Other: Placebo
  • Experimental: Cohort 2 Group A: E3112 + 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.
    Interventions:
    • Drug: E3112
    • Other: Placebo
  • Experimental: Cohort 2 Group B: Placebo + 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.
    Interventions:
    • Drug: E3112
    • Other: Placebo
  • Experimental: Cohort 3 Group A: E3112 + 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.
    Interventions:
    • Drug: E3112
    • Other: Placebo
  • Experimental: Cohort 3 Group B: Placebo + 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.
    Interventions:
    • Drug: E3112
    • Other: Placebo
  • Experimental: Cohort 4 Group A: E3112 + 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.
    Interventions:
    • Drug: E3112
    • Other: Placebo
  • Experimental: Cohort 4 Group B: Placebo + 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.
    Interventions:
    • Drug: E3112
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2021)
24
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2019)
30
Actual Study Completion Date  ICMJE October 1, 2020
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 20 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922633
Other Study ID Numbers  ICMJE E3112-CP2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eisai Inc. ( EA Pharma Co., Ltd. )
Study Sponsor  ICMJE EA Pharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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