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)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/1/2019 |
| Start Date: | July 13, 2018 |
| End Date: | February 20, 2019 |
A Randomized, Double-Blind, Parallel, Nested Crossover 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)
The purpose of this study is to assess the effects on placebo-corrected change from baseline
QT interval corrected for individual heart rate (QTcI) of JNJ-64565111 close to steady state
on Day 26 and on electrocardiogram morphology at supratherapeutic exposures in otherwise
healthy overweight/obese adults after 4 weeks of treatment with JNJ 64565111 administered
subcutaneously once weekly.
QT interval corrected for individual heart rate (QTcI) of JNJ-64565111 close to steady state
on Day 26 and on electrocardiogram morphology at supratherapeutic exposures in otherwise
healthy overweight/obese adults after 4 weeks of treatment with JNJ 64565111 administered
subcutaneously once weekly.
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)
We found this trial at
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