Clinical trial NCT04609852: A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Participants
E8001
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-30
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Screening up to Day 180 (approximately 292 days)
measure: Cmax: Maximum Observed Plasma Concentration for E8001
timeFrame: Day 1: 0-168 hours
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001
timeFrame: Day 1: 0-168 hours
measure: AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E8001
timeFrame: Day 1: 0-168 hours
measure: T1/2: Terminal Elimination Phase Half-life for E8001
timeFrame: Day 1: 0-168 hours
measure: CL: Total Clearance for E8001
timeFrame: Day 1: 0-168 hours
measure: Vss: Volume of Distribution at Steady State for E8001
timeFrame: Day 1: 0-168 hours
Secondary outcomes:
measure: Change From Baseline in Corrected QT (QTc) Interval
timeFrame: Day 1: 0-24 hours
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Eisai Trial Site #1
Study officials:
References: