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Completed

NCT Number: NCT03606057

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)

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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)

Treatment and study plan

JNJ-64565111

Drug

Participants will receive JNJ-64565111, subcutaneously on days 2, 9, 16, and 23.

moxifloxacin

Drug

Participants will receive moxifloxacin capsule on days 1 or 27 in a nested crossover manner.

JNJ-64565111-matching Placebo

Drug

Participants will receive JNJ-64565111-matching Placebo vehicle solution subcutaneously on days 2, 9, 16, and 23.

Moxifloxacin-matching placebo

Drug

Participants will receive moxifloxacin-matching placebo capsule on days 1 and 27 in treatment group 1 and on day 1 or 27 in treatment group 2.

Primary outcomes

  1. Placebo-Corrected Change from Baseline in QT Interval Corrected for Individual Heart Rate (QTcI) on Day 26 Time-Matched Time Points

    Time frame: Baseline and Day 26

    Placebo-corrected change from baseline in QT interval corrected for individual heart rate (QTcI) on day 26 time-matched time points will be determined. The mean change from baseline in QTcI for participants who receive placebo will be subtracted from the mean change from baseline in QTcI for participants on JNJ-64565111 at the same time point to generate placebo-corrected change from baseline in QTcI, which will be presented.

  2. Change from Time-Matched Baseline in QTc Interval

    Time frame: Up to Day 27

    The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).

  3. Change from Time-Matched Baseline in Heart Rate (HR)

    Time frame: Up to Day 27

    The HR will be measured by ECG.

  4. Change from Time-Matched Baseline in QRS Interval

    Time frame: Up to Day 27

    The QRS Intervals will be measured by ECG.

  5. Change from Time-Matched Baseline in PR Interval

    Time frame: Up to Day 27

    The PR intervals will be measured by ECG.

Secondary outcomes

  1. Cardiac Repolarization as Determined by Mean Change from Time-Matched Baseline in QT Interval Corrected for Individual HR (QTcI) on Day 5

    Time frame: Baseline and Day 5

    Mean change from time-matched baseline in QT interval corrected for individual HR (QTcI) on day 5 to determine the effect of JNJ-64565111 on cardiac repolarization.

  2. Cardiac Repolarization as Determined by Mean Change from Time-Matched Baseline in QT Interval Corrected For HR Using Fridericia's Formula (QTcF) on Day 5 and Day 26

    Time frame: Baseline, Day 5 and Day 26

    Mean change from time-matched baseline in QT interval corrected for HR using Fridericia's formula (QTcF) will be assessed on day 5 and day 26 to determine the effect of JNJ-64565111 on cardiac repolarization.

  3. Maximum Observed Serum Concentration (Cmax)

    Time frame: Days 1, 5, 26 and 27

    Cmax is defined as the maximum observed serum analyte concentration.

  4. Time to Reach Maximum Observed Serum Concentration (Tmax)

    Time frame: Days 1, 5, 26 and 27

    Tmax is defined as actual sampling time to reach maximum observed serum analyte concentration.

  5. Average Serum Analyte Concentration (Cavg)

    Time frame: Days 1, 5, 26 and 27

    Cavg is defined as average serum analyte concentration.

  6. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: From signing of the informed consent form (ICF) to end of study (approximately 12 weeks)

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  7. QTcI Changes Evaluated Using ECG Assessments versus Serum Concentrations of JNJ-64565111

    Time frame: Up to Day 27

    QTcI changes evaluated using ECG assessments versus serum concentrations of JNJ-64565111 will be quantified. QTcI is a QT interval corrected for heart rate using individual-specific correction formula and QTcI changes will be quantified using a linear or nonlinear mixed effects modeling approach.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2018
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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