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 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT03696459
Eligibility Criteria:
Inclusion Criteria:
* Participants must have a Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (inclusive), and body weight not less than (\<) 50 kg at screening
* Participants must have a blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
* Participants must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) Normal sinus rhythm (heart rate (HR) between 45 and 100 beats per minute (bpm), inclusive); b) QT interval corrected for HR according to Fridericia's formula (QTcF) between 350 milliseconds (ms) and 430 ms for male participants, and between 350 ms and 450 ms for female participants (inclusive); c) QRS interval of ECG \<110 ms; d) PR interval of the ECG less-than or equal to (\<=) 200 ms; e) Morphology consistent with healthy cardiac conduction and function
* A female participant must be of non-childbearing potential, defined as: a) Postmenopausal or b) Permanently sterile
* A female participant must have a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test at screening and a negative urine pregnancy test (except if postmenopausal) on Day -1 (or Day -2 in the first treatment period in Part 2)
Exclusion Criteria:
* Participants has a history of current clinically significant medical illness or certain laboratory abnormalities at screening
* Participant has a history of hepatitis A virus immunoglobulin M (IgM) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus IgM antibody, HBsAg or HCV antibody at screening
* Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
* Participants with a past history of heart arrhythmias or with a history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia or family history of short/long QT syndrome, or sudden unexplained death at a young age \[\<=40 years\], drowning or sudden infant death in a first degree relative \[that is, sibling, offspring, or biological parent\])
* Participants with any skin condition likely to interfere with ECG electrode placement or adhesion
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03696459
Study Brief:
Protocol Section:
NCT03696459