A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen Research & Development, LLC
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)
