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)

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03606057

Run by

Janssen Research & Development, LLC

People needed

188

Starts

2018-07-13

Expected to finish

2019-02-28

Last updated by the study team

2020-03-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify 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
• Normal sinus rhythm (heart rate between 45 and 100 beats per minute [inclusive])
• QT interval corrected for heart rate according to Fridericia's formula (QTcF) interval between 350 to 450 ms (inclusive)
• PR interval <= 200 ms
• ECG morphology consistent with healthy cardiac conduction and function

You may not qualify 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)

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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