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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E8001 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609852
• Other study ID #: E8001-J081-001
• Status: Completed
• Phase: Phase 1
• Start date: October 28, 2020
• Est. completion date: August 18, 2023

Study information

• Verified date: March 2023
• 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 (PK) of E8001 of single ascending dose intravenous infusions in healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria

1. Non-smoking, age greater than or equal to (>=) 20 years and less than or equal to (<=) 55 years old adult male at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing

2. Body mass index (BMI) >=18.5 and less than (<) 25.0 kilogram per square meter (kg/m^2) at Screening

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• E8001
Intravenous infusion.
• Placebo
Intravenous infusion.

Locations

Country	Name	City	State
Japan	Eisai Trial Site #1	Minato-ku

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.	Screening up to Day 180 (approximately 292 days)
Primary	Cmax: Maximum Observed Plasma Concentration for E8001		Day 1: 0-168 hours
Primary	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001		Day 1: 0-168 hours
Primary	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
Primary	T1/2: Terminal Elimination Phase Half-life for E8001		Day 1: 0-168 hours
Primary	CL: Total Clearance for E8001		Day 1: 0-168 hours
Primary	Vss: Volume of Distribution at Steady State for E8001		Day 1: 0-168 hours
Secondary	Change From Baseline in Corrected QT (QTc) Interval	To assess the effect of E8001 on ventricular repolarization by assessing the QTc interval corrected by the Fridericia formula (QTcF).	Day 1: 0-24 hours