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)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-64565111-matching Placebo; Drug: JNJ-64565111; Drug: Moxifloxacin; Drug: Moxifloxacin-matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03606057

64565111OBE1002 (Other Identifier)

CR108477

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups

Treatment Group 1: JNJ-64565111+Moxifloxacin Placebo

Experimental group

Description:

Participant will receive JNJ-64565111 on days 2, 9, 16, and 23 and moxifloxacin-matching placebo on days 1 and 27.

Treatment:

Drug: Moxifloxacin-matching Placebo

Drug: JNJ-64565111

Treatment Group 2: JNJ-64565111 Matching Placebo+Moxifloxacin

Active Comparator group

Description:

Participant will receive JNJ-64565111-matching placebo on days 2, 9, 16, and 23. Participants will also receive moxifloxacin on day 1 and moxifloxacin-matching placebo on day 27 (sequence 2a) or moxifloxacin-matching placebo on day 1 and moxifloxacin on day 27 (sequence 2b) in a nested crossover manner.

Treatment:

Drug: JNJ-64565111-matching Placebo

Drug: Moxifloxacin

Drug: Moxifloxacin-matching Placebo