Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eisai Inc.
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Nonsmoking, male or female, age ≥18 years and ≤45 years old at the time of informed consent
Body mass index (BMI) ≥18 and \<32 kilograms per meters squared (kg/m2) at Screening
You may not be if
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] or human chorionic gonadotropin \[hCG\] test with a minimum sensitivity of 25 International Units per Liter \[IU/L\] or equivalent units of β-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and 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.
Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles of E6742 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening
A prolonged QTcF interval (QTcF \>450 ms) demonstrated on ECG at Screening or Baseline
Persistent systolic blood pressure \>130 mmHg or diastolic blood pressure \>85 mmHg diastolic at Screening or Baseline Heart rate less than 50 or more than 100 beats/min at Screening or Baseline
Known history of prolonged QT/QTc interval
Left bundle branch block
Known history of myocardial infarction or active ischemic heart disease
Known history of clinically significant arrhythmia or uncontrolled arrhythmia
Known history of clinically significant drug allergy at Screening
Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
Known to be human immunodeficiency virus (HIV) positive at Screening
Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
History of drug or alcohol dependency or abuse within the 2 years prior to Screening, or those who have a positive urine drug and alcohol test at Screening or Baseline
Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
Use of prescription drugs within 4 weeks before dosing
Intake of over-the-counter (OTC) medications within 2 weeks before dosing
Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) before informed consent
Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing
Clareo Health | Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult Subjects
