HealthyPhase 1NCT03696459
A Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Participants
A Phase 1 study testing JNJ-53718678, 2000 mg, JNJ-53718678, 3000 mg and JNJ-53718678, 4500 mg or Dose to be decided in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the effect of JNJ-53718678 on QT interval corrected for heart rate (QTc) changes using exposure response analysis in healthy adult participants (Part 2). 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-53718678, 2000 mg, JNJ-53718678, 3000 mg and JNJ-53718678, 4500 mg or Dose to be decided
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Oct 2018to 13 Dec 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
- Participants must have a Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than (<) 50 kg at screening
- Participants must have a blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
- Participants must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) Normal sinus rhythm (heart rate (HR) between 45 and 100 beats per minute (bpm), inclusive); b) QT interval corrected for HR according to Fridericia's formula (QTcF) between 350 milliseconds (ms) and 430 ms for male participants, and between 350 ms and 450 ms for female participants (inclusive); c) QRS interval of ECG <110 ms; d) PR interval of the ECG less-than or equal to (<=) 200 ms; e) Morphology consistent with healthy cardiac conduction and function
- A female participant must be of non-childbearing potential, defined as: a) Postmenopausal or b) Permanently sterile
- A female participant must have a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test at screening and a negative urine pregnancy test (except if postmenopausal) on Day -1 (or Day -2 in the first treatment period in Part 2)
Who cannot join
- Participants has a history of current clinically significant medical illness or certain laboratory abnormalities at screening
- Participant has a history of hepatitis A virus immunoglobulin M (IgM) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus IgM antibody, HBsAg or HCV antibody at screening
- Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
- Participants with a past history of heart arrhythmias or with a history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia or family history of short/long QT syndrome, or sudden unexplained death at a young age [<=40 years], drowning or sudden infant death in a first degree relative [that is, sibling, offspring, or biological parent])
- Participants with any skin condition likely to interfere with ECG electrode placement or adhesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, 4-Period Cross-over Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Subjects
The purpose of this study is to assess the effect of JNJ-53718678 on QT interval corrected for heart rate (QTc) changes using exposure response analysis in healthy adult participants (Part 2).
- Conditions
- Healthy
- Being tested
- JNJ-53718678, 2000 mg, JNJ-53718678, 3000 mg, JNJ-53718678, 4500 mg or Dose to be decided, JNJ-53718678 500 mg, JNJ-53718678 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-53718678, 2000 mgDrug
Participants will be administered JNJ-53718678, 2000 mg as oral suspension in Part 1 (Panel 1).
JNJ-53718678, 3000 mgDrug
Participants will be administered JNJ- 53718678, 3000 mg as oral suspension in Part 1 (Panel 2).
JNJ-53718678, 4500 mg or Dose to be decidedDrug
Participants will be administered JNJ-53718678, 4500 mg as oral suspension in Part 1 (Panel 3). If this dose is considered safe and tolerable and if pharmacokinetic data require further dose escalation, then participants will receive JNJ-53718678 (Dose to be decided) in Part 1 (Panel 4). This dose (either from Panel 3 or Panel 4 ) will be used in Part 2 (Dose may be lower/higher based on review of safety, tolerability, and PK data obtained in Part 1).
JNJ-53718678 500 mgDrug
Participants will be administered JNJ-53718678, 500 mg as oral suspension in Part 2.
JNJ-53718678 PlaceboDrug
Participants will be administered JNJ-53718678 matching placebo in Part 1 and 2.
Moxifloxacin 400 mgDrug
Participants will be administered moxifloxacin 400 mg as capsule in Part 2.
Moxifloxacin PlaceboDrug
Participants will be administered moxifloxacin matching placebo in Part 2.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose Escalation): Panel 1 | Experimental | Participants will receive single oral dose of JNJ-53718678, 2000 milligram (mg) suspension or matching placebo on Day 1, under fasted conditions. Receives: Drug: JNJ-53718678, 2000 mg; Drug: JNJ-53718678 Placebo |
| Part 1 (Dose Escalation): Panel 2 | Experimental | Participants will receive single oral dose of JNJ-53718678, of maximum 3000 mg suspension or matching placebo on Day 1, under fasted conditions. Receives: Drug: JNJ-53718678, 3000 mg; Drug: JNJ-53718678 Placebo |
| Part 1 (Dose escalation): Panel 3 | Experimental | Participants will receive single oral dose of JNJ-53718678 4500 mg suspension (this dose may be used in Part 2, Treatment F) or matching placebo on Day 1, under fasted condition. Receives: Drug: JNJ-53718678, 4500 mg or Dose to be decided; Drug: JNJ-53718678 Placebo |
| Part 1 (Dose Escalation): Panel 4 (Optional) | Experimental | Participants will receive single oral dose of JNJ-53718678 (dose to be decided [this dose may be used in Part 2, Treatment F]) suspension or matching placebo on Day 1, under fasted condition, if 4500 mg dose in Panel 3 is considered safe and tolerable and if pharmacokinetic data require further dose escalation to reach the target exposure. Receives: Drug: JNJ-53718678, 4500 mg or Dose to be decided; Drug: JNJ-53718678 Placebo |
| Part 2 Group 1: Treatment Sequence EHFG | Experimental | Participants will receive single oral dose of JNJ-53718678, 500 mg suspension with single oral dose of moxifloxacin placebo and JNJ 53718678 placebo (Treatment E) in Period 1, then participants will receive single oral dose of moxifloxacin 400 mg with single oral dose of JNJ-53718678 placebo (Treatment H) in Period 2 then will receive single oral dose of JNJ-53718678, 4500 mg (dose will be based on review of safety, tolerability, and PK data obtained in Part 1 [either from Panel 3 or 4], this dose may be lower/higher) suspension with single oral dose of moxifloxacin placebo (Treatment F) in Period 3 followed by single oral dose of JNJ-53718678 placebo with single oral dose of moxifloxacin placebo (Treatment G) in Period 4, on Day 1 of each treatment period. There will be a washout period of at least 7 days between study drug intake in subsequent treatment periods. Receives: Drug: JNJ-53718678, 4500 mg or Dose to be decided; Drug: JNJ-53718678 500 mg; Drug: JNJ-53718678 Placebo; Drug: Moxifloxacin 400 mg; Drug: Moxifloxacin Placebo |
| Part 2 Group 2: Treatment Sequence FEGH | Experimental | Participants will receive Treatment F in Period 1, then Treatment E in Period 2, then Treatment G in Period 3 followed by Treatment H in Period 4 on Day 1 of each treatment period. Receives: Drug: JNJ-53718678, 4500 mg or Dose to be decided; Drug: JNJ-53718678 500 mg; Drug: JNJ-53718678 Placebo; Drug: Moxifloxacin 400 mg; Drug: Moxifloxacin Placebo |
| Part 2 Group 3: Treatment Sequence GFHE | Experimental | Participants will receive Treatment G in Period 1, then Treatment F in Period 2, then Treatment H in Period 3 followed by Treatment E in Period 4 on Day 1 of each treatment period. Receives: Drug: JNJ-53718678, 4500 mg or Dose to be decided; Drug: JNJ-53718678 500 mg; Drug: JNJ-53718678 Placebo; Drug: Moxifloxacin 400 mg; Drug: Moxifloxacin Placebo |
| Part 2 Group 4: Treatment Sequence HGEF | Experimental | Participants will receive Treatment H in Period 1, then Treatment G in Period 2, then Treatment E in Period 3 followed by Treatment F in Period 4 on Day 1 of each treatment period. Receives: Drug: JNJ-53718678, 4500 mg or Dose to be decided; Drug: JNJ-53718678 500 mg; Drug: JNJ-53718678 Placebo; Drug: Moxifloxacin 400 mg; Drug: Moxifloxacin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 2: Placebo-Corrected Change from Baseline in QT Interval Corrected for Heart Rate (QTc) for JNJ-53718678
Placebo-corrected change from baseline in QT interval corrected for heart rate (QTc) will be determined. The mean change from baseline in QTc in placebo treatment will be subtracted from the mean change from baseline in JNJ-53718678 treatment at the same time point to generate placebo-corrected change from baseline in QTc, which will be presented.
Measured: Baseline and Day 1
Secondary outcomes (31)
Part 1: 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: Approximately up to 9 weeks
Part 2: 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: Approximately up to 12 weeks
Part 1: Change from Baseline in QTc Interval
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).
Measured: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)
Part 1: Change from Baseline in Heart Rate (HR)
The HR will be measured by ECG.
Measured: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)
Part 1: Change from Baseline in PR Interval
The PR Intervals will be measured by ECG.
Measured: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)
Part 1: Change from Baseline in QRS Interval
The QRS Intervals will be measured by ECG.
Measured: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)
Part 1: Percentage of Participants with T-Wave Morphology Changes from Baseline
Percentage of participants with T-wave morphology (Normal T-wave, Flat T-waves, Notched T-wave (positive), Biphasic, Normal T-wave (negative), Notched T-wave (negative) changes will be noted.
Measured: Baseline up to 72 hours postdose
Part 1: Percentage of Participants with U-Wave Presence
Percentage of participants with U-wave presence will be noted.
Measured: Baseline up to 72 hours postdose
Part 2: Change from Baseline in QTc Interval
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by ECG.
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Change from Baseline in HR
The HR will be measured by ECG.
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Change from Baseline PR Interval
The PR Intervals will be measured by ECG.
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Change from Baseline QRS Interval
The QRS Intervals will be measured by ECG.
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Placebo Corrected Change from Baseline in HR
Placebo-corrected change from baseline in HR will be determined. The mean change from baseline in HR in placebo treatment will be subtracted from the mean change from baseline in JNJ-53718678 treatment at the same time point to generate placebo-corrected change from baseline in HR, which will be presented.
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Placebo Corrected Change from Baseline PR Interval
Placebo-corrected change from baseline in PR interval will be determined. The mean change from baseline in PR interval in placebo treatment will be subtracted from the mean change from baseline in JNJ-53718678 treatment at the same time point to generate placebo-corrected change from baseline in PR interval, which will be presented.
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Placebo Corrected Change from Baseline QRS Interval
Placebo-corrected change from baseline in QRS interval will be determined. The mean change from baseline in QRS interval in placebo treatment will be subtracted from the mean change from baseline in JNJ-53718678 treatment at the same time point to generate placebo-corrected change from baseline in QRS interval, which will be presented.
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Number of Participants with Categorical Outliers for QTc Interval
Number of Participants with categorical outliers defined as QTc interval values greater than (>)450 and lesser than or equal to (<=) 480 milliseconds (ms), >480 and <=500 ms, and >500 ms at any time point and change from baseline QTc >30 ms and <=60 ms, and >60 ms will be determined.
Measured: Baseline up to 24 hours postdose
Part 2: Number of Participants with Categorical Outliers for HR
Number of Participants with categorical outliers for HR will be determined for abnormality, where HR is abnormally low (<= 45 beats per minute [bpm]) and abnormally high (>= 120 bpm).
Measured: Baseline up to 24 hours postdose
Part 2: Number of Participants with Categorical Outliers for PR Interval
Number of Participants with categorical outliers for PR interval will be determined for abnormality, where PR is abnormally high (>= 210 milliseconds [ms]).
Measured: Baseline up to 24 hours postdose
Part 2: Number of Participants with Categorical Outliers for QRS Interval
Number of Participants with categorical outliers for QRS interval will be determined for abnormality, where QRS is abnormally low (<= 50 ms) and abnormally high (>=120 ms).
Measured: Baseline up to 24 hours postdose
Part 2: Percentage of Participants with T-Wave Morphology Changes from Baseline
Percentage of participants with T-wave morphology (Normal T-wave, Flat T-waves, Notched T-wave (positive), Biphasic, Normal T-wave (negative), Notched T-wave (negative) changes will be noted.
Measured: Baseline up to 24 hours postdose
Part 2: Percentage of Participants with U-Wave Presence
Percentage of participants with U-wave presence will be noted.
Measured: Baseline up to 24 hours postdose
Part 1: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Cmax is defined as the maximum observed plasma concentration. Cmax will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Tmax is defined as actual sampling time to reach maximum observed plasma concentration. Tmax will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 1: Plasma concentration at 24 hours post dosing (C24h) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
C24h is defined as the plasma concentration at 24 hours post dosing. C24h will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24hours postdose
Part 1: Area Under the Plasma Concentration-time Curve from Time 0 to 24 hours (AUC [0-24]) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
AUC (0-24) is defined as the area under the plasma concentration-time curve from time 0 to 24 hours. AUC (0-24) will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 1: Area Under the Plasma Concentration-time Curve from Time Zero to the Time of Last Measurable Concentration (AUC [0-last]) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
AUC(0-last) is defined as the area under the plasma concentration-time curve from time 0 to the time of the last measurable (non-below quantification level [non-BQL]) plasma concentration calculated by linear-linear trapezoidal summation. AUC [0-last] will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 1: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
AUC (0-infinity) is defined as the area under the plasma concentration vs. time curve from time 0 to infinite time, calculated as AUC (0-last) + Clast/ lambda (z), where Clast is the last observed measurable (non- BQL) plasma concentration. AUC (0-infinity) will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 1: Apparent Elimination Half-Life (T1/2) of JNJ- 53718678 and its Metabolites (M5, M12, M19, and M37)
T1/2 is defined as apparent terminal elimination half-life and is calculated as 0.693/lambda(z) and will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Cmax is defined as the maximum observed plasma concentration. Cmax will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Tmax is defined as actual sampling time to reach maximum observed plasma concentration. Tmax will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Area Under the Plasma Concentration-time Curve from Time 0 to 24 hours (AUC [0-24]) of JNJ-53718678
AUC (0-24) is defined as the area under the plasma concentration-time curve from time 0 to 24 hours. AUC (0-24) will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start2 Oct 2018
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696459
- Sponsor's protocol ID
- CR108519
- Other IDs
- 2018-000878-30, 53718678RSV1009, 2018
- Status last verified
- Feb 2020
- First submitted
- 3 Oct 2018
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, 4-Period Cross-over Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03696459
- Acronym / sponsor ID
- CR108519
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of JNJ-53718678 on QT interval corrected for heart rate (QTc) changes using exposure response analysis in healthy adult participants (Part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Dose Escalation): Panel 1 | Experimental | Drug: JNJ-53718678, 2000 mg, Drug: JNJ-53718678 PlaceboParticipants will receive single oral dose of JNJ-53718678, 2000 milligram (mg) suspension or matching placebo on Day 1, under fasted conditions. |
| Part 1 (Dose Escalation): Panel 2 | Experimental | Drug: JNJ-53718678, 3000 mg, Drug: JNJ-53718678 PlaceboParticipants will receive single oral dose of JNJ-53718678, of maximum 3000 mg suspension or matching placebo on Day 1, under fasted conditions. |
| Part 1 (Dose escalation): Panel 3 | Experimental | Drug: JNJ-53718678, 4500 mg or Dose to be decided, Drug: JNJ-53718678 PlaceboParticipants will receive single oral dose of JNJ-53718678 4500 mg suspension (this dose may be used in Part 2, Treatment F) or matching placebo on Day 1, under fasted condition. |
| Part 1 (Dose Escalation): Panel 4 (Optional) | Experimental | Drug: JNJ-53718678, 4500 mg or Dose to be decided, Drug: JNJ-53718678 PlaceboParticipants will receive single oral dose of JNJ-53718678 (dose to be decided [this dose may be used in Part 2, Treatment F]) suspension or matching placebo on Day 1, under fasted condition, if 4500 mg dose in Panel 3 is considered safe and tolerable and if pharmacokinetic data require further dose escalation to reach the target exposure. |
| Part 2 Group 1: Treatment Sequence EHFG | Experimental | Drug: JNJ-53718678, 4500 mg or Dose to be decided, Drug: JNJ-53718678 500 mg, Drug: JNJ-53718678 Placebo, Drug: Moxifloxacin 400 mg, Drug: Moxifloxacin PlaceboParticipants will receive single oral dose of JNJ-53718678, 500 mg suspension with single oral dose of moxifloxacin placebo and JNJ 53718678 placebo (Treatment E) in Period 1, then participants will receive single oral dose of moxifloxacin 400 mg with single oral dose of JNJ-53718678 placebo (Treatment H) in Period 2 then will receive single oral dose of JNJ-53718678, 4500 mg (dose will be based on review of safety, tolerability, and PK data obtained in Part 1 [either from Panel 3 or 4], this dose may be lower/higher) suspension with single oral dose of moxifloxacin placebo (Treatment F) in Period 3 followed by single oral dose of JNJ-53718678 placebo with single oral dose of moxifloxacin placebo (Treatment G) in Period 4, on Day 1 of each treatment period. There will be a washout period of at least 7 days between study drug intake in subsequent treatment periods. |
| Part 2 Group 2: Treatment Sequence FEGH | Experimental | Drug: JNJ-53718678, 4500 mg or Dose to be decided, Drug: JNJ-53718678 500 mg, Drug: JNJ-53718678 Placebo, Drug: Moxifloxacin 400 mg, Drug: Moxifloxacin PlaceboParticipants will receive Treatment F in Period 1, then Treatment E in Period 2, then Treatment G in Period 3 followed by Treatment H in Period 4 on Day 1 of each treatment period. |
| Part 2 Group 3: Treatment Sequence GFHE | Experimental | Drug: JNJ-53718678, 4500 mg or Dose to be decided, Drug: JNJ-53718678 500 mg, Drug: JNJ-53718678 Placebo, Drug: Moxifloxacin 400 mg, Drug: Moxifloxacin PlaceboParticipants will receive Treatment G in Period 1, then Treatment F in Period 2, then Treatment H in Period 3 followed by Treatment E in Period 4 on Day 1 of each treatment period. |
| Part 2 Group 4: Treatment Sequence HGEF | Experimental | Drug: JNJ-53718678, 4500 mg or Dose to be decided, Drug: JNJ-53718678 500 mg, Drug: JNJ-53718678 Placebo, Drug: Moxifloxacin 400 mg, Drug: Moxifloxacin PlaceboParticipants will receive Treatment H in Period 1, then Treatment G in Period 2, then Treatment E in Period 3 followed by Treatment F in Period 4 on Day 1 of each treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must have a Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than (<) 50 kg at screening
- Participants must have a blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
- Participants must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) Normal sinus rhythm (heart rate (HR) between 45 and 100 beats per minute (bpm), inclusive); b) QT interval corrected for HR according to Fridericia's formula (QTcF) between 350 milliseconds (ms) and 430 ms for male participants, and between 350 ms and 450 ms for female participants (inclusive); c) QRS interval of ECG <110 ms; d) PR interval of the ECG less-than or equal to (<=) 200 ms; e) Morphology consistent with healthy cardiac conduction and function
- A female participant must be of non-childbearing potential, defined as: a) Postmenopausal or b) Permanently sterile
- A female participant must have a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test at screening and a negative urine pregnancy test (except if postmenopausal) on Day -1 (or Day -2 in the first treatment period in Part 2)
Key exclusion criteria (5 listed)
- Participants has a history of current clinically significant medical illness or certain laboratory abnormalities at screening
- Participant has a history of hepatitis A virus immunoglobulin M (IgM) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus IgM antibody, HBsAg or HCV antibody at screening
- Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
- Participants with a past history of heart arrhythmias or with a history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia or family history of short/long QT syndrome, or sudden unexplained death at a young age [<=40 years], drowning or sudden infant death in a first degree relative [that is, sibling, offspring, or biological parent])
- Participants with any skin condition likely to interfere with ECG electrode placement or adhesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-53718678, 2000 mgParticipants will be administered JNJ-53718678, 2000 mg as oral suspension in Part 1 (Panel 1). | Drug | Part 1 (Dose Escalation): Panel 1 |
| JNJ-53718678, 3000 mgParticipants will be administered JNJ- 53718678, 3000 mg as oral suspension in Part 1 (Panel 2). | Drug | Part 1 (Dose Escalation): Panel 2 |
| JNJ-53718678, 4500 mg or Dose to be decidedParticipants will be administered JNJ-53718678, 4500 mg as oral suspension in Part 1 (Panel 3). If this dose is considered safe and tolerable and if pharmacokinetic data require further dose escalation, then participants will receive JNJ-53718678 (Dose to be decided) in Part 1 (Panel 4). This dose (either from Panel 3 or Panel 4 ) will be used in Part 2 (Dose may be lower/higher based on review of safety, tolerability, and PK data obtained in Part 1). | Drug | Part 1 (Dose Escalation): Panel 4 (Optional), Part 1 (Dose escalation): Panel 3, Part 2 Group 1: Treatment Sequence EHFG, Part 2 Group 2: Treatment Sequence FEGH, Part 2 Group 3: Treatment Sequence GFHE, Part 2 Group 4: Treatment Sequence HGEF |
| JNJ-53718678 500 mgParticipants will be administered JNJ-53718678, 500 mg as oral suspension in Part 2. | Drug | Part 2 Group 1: Treatment Sequence EHFG, Part 2 Group 2: Treatment Sequence FEGH, Part 2 Group 3: Treatment Sequence GFHE, Part 2 Group 4: Treatment Sequence HGEF |
| JNJ-53718678 PlaceboParticipants will be administered JNJ-53718678 matching placebo in Part 1 and 2. | Drug | Part 1 (Dose Escalation): Panel 1, Part 1 (Dose Escalation): Panel 2, Part 1 (Dose Escalation): Panel 4 (Optional), Part 1 (Dose escalation): Panel 3, Part 2 Group 1: Treatment Sequence EHFG, Part 2 Group 2: Treatment Sequence FEGH, Part 2 Group 3: Treatment Sequence GFHE, Part 2 Group 4: Treatment Sequence HGEF |
| Moxifloxacin 400 mgParticipants will be administered moxifloxacin 400 mg as capsule in Part 2. | Drug | Part 2 Group 1: Treatment Sequence EHFG, Part 2 Group 2: Treatment Sequence FEGH, Part 2 Group 3: Treatment Sequence GFHE, Part 2 Group 4: Treatment Sequence HGEF |
| Moxifloxacin PlaceboParticipants will be administered moxifloxacin matching placebo in Part 2. | Drug | Part 2 Group 1: Treatment Sequence EHFG, Part 2 Group 2: Treatment Sequence FEGH, Part 2 Group 3: Treatment Sequence GFHE, Part 2 Group 4: Treatment Sequence HGEF |
Primary outcome
Part 2: Placebo-Corrected Change from Baseline in QT Interval Corrected for Heart Rate (QTc) for JNJ-53718678
Time frame: Baseline and Day 1
Placebo-corrected change from baseline in QT interval corrected for heart rate (QTc) will be determined. The mean change from baseline in QTc in placebo treatment will be subtracted from the mean change from baseline in JNJ-53718678 treatment at the same time point to generate placebo-corrected change from baseline in QTc, which will be presented.
31 secondary outcomes
Part 1: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately up to 9 weeks
Part 2: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately up to 12 weeks
Part 1: Change from Baseline in QTc Interval
Time frame: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)
Part 1: Change from Baseline in Heart Rate (HR)
Time frame: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)
Part 1: Change from Baseline in PR Interval
Time frame: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)
Part 1: Change from Baseline in QRS Interval
Time frame: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)
Part 1: Percentage of Participants with T-Wave Morphology Changes from Baseline
Time frame: Baseline up to 72 hours postdose
Part 1: Percentage of Participants with U-Wave Presence
Time frame: Baseline up to 72 hours postdose
Part 2: Change from Baseline in QTc Interval
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Change from Baseline in HR
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Change from Baseline PR Interval
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Change from Baseline QRS Interval
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Placebo Corrected Change from Baseline in HR
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Placebo Corrected Change from Baseline PR Interval
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Placebo Corrected Change from Baseline QRS Interval
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Number of Participants with Categorical Outliers for QTc Interval
Time frame: Baseline up to 24 hours postdose
Part 2: Number of Participants with Categorical Outliers for HR
Time frame: Baseline up to 24 hours postdose
Part 2: Number of Participants with Categorical Outliers for PR Interval
Time frame: Baseline up to 24 hours postdose
Part 2: Number of Participants with Categorical Outliers for QRS Interval
Time frame: Baseline up to 24 hours postdose
Part 2: Percentage of Participants with T-Wave Morphology Changes from Baseline
Time frame: Baseline up to 24 hours postdose
Part 2: Percentage of Participants with U-Wave Presence
Time frame: Baseline up to 24 hours postdose
Part 1: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 1: Plasma concentration at 24 hours post dosing (C24h) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24hours postdose
Part 1: Area Under the Plasma Concentration-time Curve from Time 0 to 24 hours (AUC [0-24]) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 1: Area Under the Plasma Concentration-time Curve from Time Zero to the Time of Last Measurable Concentration (AUC [0-last]) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 1: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 1: Apparent Elimination Half-Life (T1/2) of JNJ- 53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours postdose
Part 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Part 2: Area Under the Plasma Concentration-time Curve from Time 0 to 24 hours (AUC [0-24]) of JNJ-53718678
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- To learn how to participate in this trial please click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-53718678, 2000 mg, JNJ-53718678, 3000 mg and JNJ-53718678, 4500 mg or Dose to be decided in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 5 inclusion and 5 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 18 Feb 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 Belgium. 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?
Part 2: Placebo-Corrected Change from Baseline in QT Interval Corrected for Heart Rate (QTc) for JNJ-53718678 (time frame: Baseline and Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2020.