NCT03922633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

April 16, 2019

Last Update Submit

March 11, 2021

Conditions

Healthy Male Participants

Keywords

E3112Phase 1PharmacokineticsJapanese

Outcome Measures

Primary Outcomes (9)

  • 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

    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

  • 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

  • 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

  • Area Under the Concentration-time Curve (AUC∞) of E3112

    AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.

    Day 1: 0-24 hours; Day 8: 0-24 hours

  • 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

  • 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

  • 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 Outcomes (9)

  • 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 Hematology parameter value

    Day 1 to Day 43

  • Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value

    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

  • +4 more secondary outcomes

Study Arms (8)

Cohort 1 Group A: E3112 + Placebo

EXPERIMENTAL

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: E3112Other: Placebo

Cohort 1 Group B: Placebo + E3112

EXPERIMENTAL

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: E3112Other: Placebo

Cohort 2 Group A: E3112 + Placebo

EXPERIMENTAL

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: E3112Other: Placebo

Cohort 2 Group B: Placebo + E3112

EXPERIMENTAL

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: E3112Other: Placebo

Cohort 3 Group A: E3112 + Placebo

EXPERIMENTAL

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: E3112Other: Placebo

Cohort 3 Group B: Placebo + E3112

EXPERIMENTAL

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: E3112Other: Placebo

Cohort 4 Group A: E3112 + Placebo

EXPERIMENTAL

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: E3112Other: Placebo

Cohort 4 Group B: Placebo + E3112

EXPERIMENTAL

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: E3112Other: Placebo

Interventions

E3112DRUG

Intravenous infusion.

Cohort 1 Group A: E3112 + PlaceboCohort 1 Group B: Placebo + E3112Cohort 2 Group A: E3112 + PlaceboCohort 2 Group B: Placebo + E3112Cohort 3 Group A: E3112 + PlaceboCohort 3 Group B: Placebo + E3112Cohort 4 Group A: E3112 + PlaceboCohort 4 Group B: Placebo + E3112
PlaceboOTHER

Intravenous infusion.

Cohort 1 Group A: E3112 + PlaceboCohort 1 Group B: Placebo + E3112Cohort 2 Group A: E3112 + PlaceboCohort 2 Group B: Placebo + E3112Cohort 3 Group A: E3112 + PlaceboCohort 3 Group B: Placebo + E3112Cohort 4 Group A: E3112 + PlaceboCohort 4 Group B: Placebo + E3112

Eligibility Criteria

Age20 Years - 44 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EA Pharma Trial Site

Higashi, Fukuoka, Japan

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 22, 2019

Study Start

April 22, 2019

Primary Completion

May 20, 2020

Study Completion

October 1, 2020

Last Updated

March 15, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)