A Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-53718678, 2000 mg; Drug: JNJ-53718678, 4500 mg or Dose to be decided; Drug: JNJ-53718678, 3000 mg; Drug: JNJ-53718678 500 mg; Drug: JNJ-53718678 Placebo; Drug: Moxifloxacin 400 mg; Drug: Moxifloxacin Placebo

• Registration Number: NCT03696459
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Primary Completion: 2019-12-13
• Study Completion: 2019-12-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2 Group 1: Treatment Sequence EHFG	Moxifloxacin 400 mg	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.
Part 2 Group 1: Treatment Sequence EHFG	Moxifloxacin Placebo	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.
Part 2 Group 4: Treatment Sequence HGEF	Moxifloxacin 400 mg	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.
Part 2 Group 4: Treatment Sequence HGEF	Moxifloxacin Placebo	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.
Part 2 Group 2: Treatment Sequence FEGH	Moxifloxacin 400 mg	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.
Part 2 Group 2: Treatment Sequence FEGH	JNJ-53718678 Placebo	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.
Part 1 (Dose Escalation): Panel 1	JNJ-53718678, 2000 mg	Participants 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 1	JNJ-53718678 Placebo	Participants 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	JNJ-53718678 Placebo	Participants 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	JNJ-53718678 Placebo	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.
Part 1 (Dose Escalation): Panel 4 (Optional)	JNJ-53718678 Placebo	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.
Part 2 Group 1: Treatment Sequence EHFG	JNJ-53718678, 4500 mg or Dose to be decided	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.
Part 2 Group 1: Treatment Sequence EHFG	JNJ-53718678 Placebo	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.
Part 2 Group 2: Treatment Sequence FEGH	Moxifloxacin Placebo	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.
Part 2 Group 3: Treatment Sequence GFHE	JNJ-53718678 Placebo	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.
Part 2 Group 3: Treatment Sequence GFHE	Moxifloxacin 400 mg	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.
Part 2 Group 3: Treatment Sequence GFHE	Moxifloxacin Placebo	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.
Part 2 Group 4: Treatment Sequence HGEF	JNJ-53718678, 4500 mg or Dose to be decided	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.
Part 2 Group 4: Treatment Sequence HGEF	JNJ-53718678 500 mg	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.
Part 2 Group 4: Treatment Sequence HGEF	JNJ-53718678 Placebo	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.
Part 1 (Dose Escalation): Panel 2	JNJ-53718678, 3000 mg	Participants will receive single oral dose of JNJ-53718678, of maximum 3000 mg suspension or matching placebo on Day 1, under fasted conditions.
Part 2 Group 2: Treatment Sequence FEGH	JNJ-53718678 500 mg	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.
Part 1 (Dose escalation): Panel 3	JNJ-53718678, 4500 mg or Dose to be decided	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.
Part 1 (Dose Escalation): Panel 4 (Optional)	JNJ-53718678, 4500 mg or Dose to be decided	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.
Part 2 Group 1: Treatment Sequence EHFG	JNJ-53718678 500 mg	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.
Part 2 Group 2: Treatment Sequence FEGH	JNJ-53718678, 4500 mg or Dose to be decided	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.
Part 2 Group 3: Treatment Sequence GFHE	JNJ-53718678 500 mg	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.
Part 2 Group 3: Treatment Sequence GFHE	JNJ-53718678, 4500 mg or Dose to be decided	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.

Primary Outcome Measures

Name	Time	Method
Part 2: Placebo-Corrected Change from Baseline in QT Interval Corrected for Heart Rate (QTc) for JNJ-53718678	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.

Secondary Outcome Measures

Name	Time	Method
Part 1: Change from Baseline in Heart Rate (HR)	Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)	The HR will be measured by ECG.
Part 1: Change from Baseline in PR Interval	Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)	The PR Intervals will be measured by ECG.
Part 1: Change from Baseline in QRS Interval	Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)	The QRS Intervals will be measured by ECG.
Part 1: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)	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	Cmax is defined as the maximum observed plasma concentration. Cmax will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)	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	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).
Part 1: Plasma concentration at 24 hours post dosing (C24h) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24hours postdose	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).
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)	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	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).
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)	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	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).
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)	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	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).
Part 1: Percentage of Participants with T-Wave Morphology Changes from Baseline	Baseline up to 72 hours postdose	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.
Part 1: Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Approximately up to 9 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.
Part 2: Placebo Corrected Change from Baseline PR Interval	Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	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.
Part 2: Number of Participants with Categorical Outliers for QTc Interval	Baseline up to 24 hours postdose	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.
Part 2: Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Approximately up to 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.
Part 1: Change from Baseline in QTc Interval	Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)	The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).
Part 1: Percentage of Participants with U-Wave Presence	Baseline up to 72 hours postdose	Percentage of participants with U-wave presence will be noted.
Part 2: Change from Baseline in QTc Interval	Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by ECG.
Part 2: Change from Baseline PR Interval	Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	The PR Intervals will be measured by ECG.
Part 2: Change from Baseline QRS Interval	Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	The QRS Intervals will be measured by ECG.
Part 2: Placebo Corrected Change from Baseline in HR	Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	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.
Part 2: Change from Baseline in HR	Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	The HR will be measured by ECG.
Part 2: Placebo Corrected Change from Baseline QRS Interval	Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	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.
Part 2: Number of Participants with Categorical Outliers for HR	Baseline up to 24 hours postdose	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).
Part 2: Number of Participants with Categorical Outliers for PR Interval	Baseline up to 24 hours postdose	Number of Participants with categorical outliers for PR interval will be determined for abnormality, where PR is abnormally high (\>= 210 milliseconds \[ms\]).
Part 2: Number of Participants with Categorical Outliers for QRS Interval	Baseline up to 24 hours postdose	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).
Part 2: Percentage of Participants with T-Wave Morphology Changes from Baseline	Baseline up to 24 hours postdose	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.
Part 2: Percentage of Participants with U-Wave Presence	Baseline up to 24 hours postdose	Percentage of participants with U-wave presence will be noted.
Part 1: Apparent Elimination Half-Life (T1/2) of JNJ- 53718678 and its Metabolites (M5, M12, M19, and M37)	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	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).
Part 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	Cmax is defined as the maximum observed plasma concentration. Cmax will be assessed for JNJ-53718678 and its metabolites (M5, M12, M19, and M37).
Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-53718678 and its Metabolites (M5, M12, M19, and M37)	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	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).
Part 2: Area Under the Plasma Concentration-time Curve from Time 0 to 24 hours (AUC [0-24]) of JNJ-53718678	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose	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).

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇧🇪 Merksem, Belgium