A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: E8001; Drug: Placebo

• Registration Number: NCT04609852
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E8001 of single ascending dose intravenous infusions in healthy male participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study Start: 2020-10-28
• Study First Posted: 2020-10-30
• Status Verified: 2023-03
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

1. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation

2. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing

3. History of meningococcal infection or pneumococcal infection

4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example- psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism

5. Any history of gastrointestinal surgery that may affect PK profiles of E8001, example- hepatectomy, nephrectomy, and digestive organ resection at Screening

6. Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline

7. History of prolonged QT/QTc interval

8. History of left bundle branch block (LBBB)

9. History of myocardial infarction (MI) or active ischemic heart disease (IHD)

10. History of clinically significant arrhythmia or uncontrolled arrhythmia

11. Active viral hepatitis (A, B or C) and syphilis as demonstrated by positive serology at Screening

12. History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline

13. Liver function test with following values at Screening or Baseline:

    1. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or gamma glutamyl transpeptidase (GGT): greater than (>) upper limit of normal (ULN)
    2. direct bilirubin or total bilirubin: >1.5*ULN

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: E8001 or Placebo	Placebo	Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Cohort 3: E8001 or Placebo	Placebo	Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Cohort 1: E8001 or Placebo	Placebo	Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Cohort 4: E8001 or Placebo	Placebo	Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Cohort 1: E8001 or Placebo	E8001	Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Cohort 4: E8001 or Placebo	E8001	Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Cohort 2: E8001 or Placebo	E8001	Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Cohort 3: E8001 or Placebo	E8001	Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.

Primary Outcome Measures

Name	Time	Method
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001	Day 1: 0-168 hours
AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E8001	Day 1: 0-168 hours
T1/2: Terminal Elimination Phase Half-life for E8001	Day 1: 0-168 hours
CL: Total Clearance for E8001	Day 1: 0-168 hours
Vss: Volume of Distribution at Steady State for E8001	Day 1: 0-168 hours
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Screening up to Day 180 (approximately 292 days)	Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs; regular monitoring of clinical laboratory parameters; and periodic measurement of vital signs and 12-lead electrocardiogram (ECG), body weight and physical examinations.
Cmax: Maximum Observed Plasma Concentration for E8001	Day 1: 0-168 hours

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Corrected QT (QTc) Interval	Day 1: 0-24 hours	To assess the effect of E8001 on ventricular repolarization by assessing the QTc interval corrected by the Fridericia formula (QTcF).

Trial Locations

Locations (1)

Eisai Trial Site #1; 🇯🇵 Minato-ku, Japan