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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT03606057
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 25.0 and 40.0 kilogram per square meter ( kg/m\^2), inclusive, and a body weight of not less than 80 kg
* Blood pressure (BP) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
* If a woman, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening
* If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study (from screening through Day 56) or until 30 days after the last dose of study drug for participants that withdraw early from the study
* QRS interval of less than or equal to (\<=) 110 milliseconds (ms)
* An average of triplicate 12-lead safety electrocardiogram (ECG) recording, completed within 4 minutes total, consistent with normal cardiac conduction and function at screening, including
1. Normal sinus rhythm (heart rate between 45 and 100 beats per minute \[inclusive\])
2. QT interval corrected for heart rate according to Fridericia's formula (QTcF) interval between 350 to 450 ms (inclusive)
3. PR interval \<= 200 ms
4. ECG morphology consistent with healthy cardiac conduction and function
Exclusion Criteria:
* Taken any disallowed therapies as defined in a protocol before the planned first dose of study drug
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study
* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram at screening or at admission to the study site
* Known allergies, hypersensitivity, or intolerance to JNJ-64565111, moxifloxacin, or its excipients
* Hepatitis B or C infection
* History of additional risk factors for torsade de pointes or the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (\<= 40 years), or sudden infant death syndrome in a first-degree relative (that is biological parent, sibling, or child)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03606057
Study Brief:
Protocol Section:
NCT03606057