Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT03082235
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03082235
Study Brief:
Protocol Section:
NCT03082235