A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E8001 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
- •Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- •History of meningococcal infection or pneumococcal infection
- •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
- •Any history of gastrointestinal surgery that may affect PK profiles of E8001, example- hepatectomy, nephrectomy, and digestive organ resection at Screening
- •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
- •History of prolonged QT/QTc interval
- •History of left bundle branch block (LBBB)
- •History of myocardial infarction (MI) or active ischemic heart disease (IHD)
- •History of clinically significant arrhythmia or uncontrolled arrhythmia
Arms & Interventions
Cohort 2: E8001 or Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Intervention: Placebo
Cohort 3: E8001 or Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Intervention: E8001
Cohort 1: E8001 or Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Intervention: E8001
Cohort 1: E8001 or Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Intervention: Placebo
Cohort 2: E8001 or Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Intervention: E8001
Cohort 3: E8001 or Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Intervention: Placebo
Cohort 4: E8001 or Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Intervention: E8001
Cohort 4: E8001 or Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Intervention: Placebo
Outcomes
Primary Outcomes
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001
Time Frame: 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
Time Frame: Day 1: 0-168 hours
T1/2: Terminal Elimination Phase Half-life for E8001
Time Frame: Day 1: 0-168 hours
CL: Total Clearance for E8001
Time Frame: Day 1: 0-168 hours
Vss: Volume of Distribution at Steady State for E8001
Time Frame: Day 1: 0-168 hours
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: 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
Time Frame: Day 1: 0-168 hours
Secondary Outcomes
- Change From Baseline in Corrected QT (QTc) Interval(Day 1: 0-24 hours)