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

• Sponsor: Eisai Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04609852
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 35.1
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: E8001; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Oct 28, 2020
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: E8001 or Placebo Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.	Drug: E8001; Intravenous infusion.; Drug: Placebo; Intravenous infusion.
Experimental: Cohort 2: E8001 or Placebo Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.	Drug: E8001; Intravenous infusion.; Drug: Placebo; Intravenous infusion.
Experimental: Cohort 3: E8001 or Placebo Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.	Drug: E8001; Intravenous infusion.; Drug: Placebo; Intravenous infusion.
Experimental: Cohort 4: E8001 or Placebo Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.	Drug: E8001; Intravenous infusion.; Drug: Placebo; Intravenous infusion.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Cmax: Maximum Observed Plasma Concentration for E8001 [Day 1: 0-168 hours]

3. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001 [Day 1: 0-168 hours]

4. 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]

5. T1/2: Terminal Elimination Phase Half-life for E8001 [Day 1: 0-168 hours]

6. CL: Total Clearance for E8001 [Day 1: 0-168 hours]

7. Vss: Volume of Distribution at Steady State for E8001 [Day 1: 0-168 hours]

Secondary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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:

14. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or gamma glutamyl transpeptidase (GGT): greater than (>) upper limit of normal (ULN)

15. direct bilirubin or total bilirubin: >1.5*ULN

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Eisai Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04609852
• Other Study ID Numbers: E8001-J081-001
• First Posted: Oct 30, 2020
• Last Update Posted: Aug 4, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eisai Co., Ltd.: Healthy Participants; E8001

Study Results

No Results Posted as of Aug 4, 2022