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AzTrials

HealthyPhase 1NCT03606057

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)

A Phase 1 study testing JNJ-64565111 and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-64565111 and Moxifloxacin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
1 siteUnited States
Study dates
13 Jul 2018to 28 Feb 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Celerion

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official 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)

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.

Conditions
Healthy
Being tested
JNJ-64565111, Moxifloxacin, JNJ-64565111-matching Placebo, Moxifloxacin-matching Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64565111Drug

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

  • MoxifloxacinDrug

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

  • JNJ-64565111-matching PlaceboDrug

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

  • Moxifloxacin-matching PlaceboDrug

    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.

Study groups in NCT03606057
Study groupRoleWhat they receive
Treatment Group 1: JNJ-64565111+Moxifloxacin PlaceboExperimentalParticipant will receive JNJ-64565111 on days 2, 9, 16, and 23 and moxifloxacin-matching placebo on days 1 and 27.
Receives: Drug: JNJ-64565111; Drug: Moxifloxacin-matching Placebo
Treatment Group 2: JNJ-64565111 Matching Placebo+MoxifloxacinActive comparatorParticipant 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.
Receives: Drug: Moxifloxacin; Drug: JNJ-64565111-matching Placebo; Drug: Moxifloxacin-matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline and Day 26

  2. Change from Time-Matched Baseline in QTc Interval

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

    Measured: Up to Day 27

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

    The HR will be measured by ECG.

    Measured: Up to Day 27

  4. Change from Time-Matched Baseline in QRS Interval

    The QRS Intervals will be measured by ECG.

    Measured: Up to Day 27

  5. Change from Time-Matched Baseline in PR Interval

    The PR intervals will be measured by ECG.

    Measured: Up to Day 27

Secondary outcomes (7)

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

    Measured: Baseline and Day 5

  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

    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.

    Measured: Baseline, Day 5 and Day 26

  3. Maximum Observed Serum Concentration (Cmax)

    Cmax is defined as the maximum observed serum analyte concentration.

    Measured: Days 1, 5, 26 and 27

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

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

    Measured: Days 1, 5, 26 and 27

  5. Average Serum Analyte Concentration (Cavg)

    Cavg is defined as average serum analyte concentration.

    Measured: Days 1, 5, 26 and 27

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

    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.

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

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

    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.

    Measured: Up to Day 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2018
  2. Study start13 Jul 2018
  3. Primary completion8 Feb 2019
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03606057
Sponsor's protocol ID
CR108477
Other IDs
64565111OBE1002
Status last verified
Mar 2020
First submitted
10 Jul 2018
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64565111 and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03606057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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