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)

NCT ID: NCT03606057

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-13
• Study Completion Date: 2019-02-28

Brief 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 weeks of treatment with JNJ 64565111 administered subcutaneously once weekly.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group 1: JNJ-64565111+Moxifloxacin Placebo

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

Group Type: EXPERIMENTAL

JNJ-64565111

Intervention Type: DRUG

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

Moxifloxacin-matching Placebo

Intervention Type: 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.

Treatment Group 2: JNJ-64565111 Matching Placebo+Moxifloxacin

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.

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

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

JNJ-64565111-matching Placebo

Intervention Type: DRUG

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

Moxifloxacin-matching Placebo

Intervention Type: 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.

Interventions

JNJ-64565111

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

Intervention Type: DRUG

Moxifloxacin

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

Intervention Type: DRUG

JNJ-64565111-matching Placebo

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

Intervention Type: DRUG

Moxifloxacin-matching Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

64565111OBE1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108477

Identifier Type: -

Identifier Source: org_study_id