Recent Updates
Recently added Catalysts

JNJ-53718678

Phase 2

Respiratory Syncytial Virus Infections | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Feb 4, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment138

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-53718678 · 8 trials · 2 indications

Phase 2 2Phase 1 6
NCT03379675A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial VirusRespiratory Syncytial Virus Infections
COMPLETED72 Analytics
NCT02387606Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.Respiratory Syncytial Virus Infections
COMPLETED66 Analytics
PHASE2COMPLETED
A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
Respiratory Syncytial Virus InfectionsUnlock trial analytics
PHASE2COMPLETED
Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.
Respiratory Syncytial Virus InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3
Baseline through Day 3

Area under the RSV VL-time curve (AUC) was determined as log10 copies\*hour per milliliter (Log10 copies\*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
Baseline through Day 5

Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
Baseline through Day 8

Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
Baseline through Day 14

Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Change From Baseline in RSV Viral Load at Day 3
Baseline to Day 3

Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Change From Baseline in RSV Viral Load at Day 5
Baseline to Day 5

Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Change From Baseline in RSV Viral Load at Day 8
Baseline to Day 8

Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Change From Baseline in RSV Viral Load at Day 14
Baseline to Day 14

Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Change From Baseline in RSV Viral Load at Day 21
Baseline to Day 21

Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Baseline
Baseline

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 3
Day 3

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 5
Day 5

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 8
Day 8

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 14
Day 14

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 21
Day 21

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time to Undetectable RSV Viral Load
Up to Day 21

The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.

Percentage of Participants With Undetectable RSV Viral Load at Day 3
Day 3

Percentage of participants with undetectable RSV viral load at Day 3 were reported.

Percentage of Participants With Undetectable RSV Viral Load at Day 5
Day 5

Percentage of participants with undetectable RSV viral load at Day 5 were reported.

Percentage of Participants With Undetectable RSV Viral Load at Day 8
Day 8

Percentage of participants with undetectable RSV viral load at Day 8 were reported.

Percentage of Participants With Undetectable RSV Viral Load at Day 14
Day 14

Percentage of participants with undetectable RSV viral load at Day 14 were reported.

Percentage of Participants With Undetectable RSV Viral Load at Day 21
Day 21

Percentage of participants with undetectable RSV viral load at Day 21 were reported.

Area Under the Viral Load-time Curve (VL AUC)
up to Follow-up (Day 28)

VL AUC for RSV-A Memphis 37b will be determined by quantitative reverse transcriptase -polymerase chain reaction (qRT-PCR) assay of nasal wash. The VL AUC will be calculated based on the viral load values measured 2 times per day, starting with the last value prior to first dosing, and ending with the last available value before discharge.

Observed Plasma Analyte Concentration (Ctrough) of JNJ-53718678
Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose

Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.

Ctrough of JNJ-64417184
Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose

Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.

Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-53718678
Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose

Cmax is defined as maximum observed plasma analyte concentration.

Cmax of JNJ-64417184
Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose

Cmax is defined as maximum observed plasma analyte concentration.

Area Under the Plasma Concentration-time Curve from Time of Administration up to 24 Hours Postdose (AUC[24h]) of JNJ-53718678
Up to 24 hours postdose

AUC24h is defined as AUC from time 0 to 24 hours postdose.

AUC24h of JNJ-64417184
Up to 24 hours postdose

AUC24h is defined as AUC from time 0 to 24 hours postdose.

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.

Mass Balance of JNJ-53718678 in Healthy Adult Male Participants.
Up to Day 10

Total mass balance calculated by D(dose) urine, total (percent \[%\]) + D feces, total (%) + D duodenal, total (%) where D urine, total is the total percentage of the dose excreted into urine, calculated as 100 \* (Ae total \[total amount excreted into urine, calculated by adding the amounts of the individual intervals together\] /Dose); D feces,total is the total percentage of the dose excreted into feces, calculated as 100 \* (Ae total \[total amount excreted into feces, calculated by adding the amounts of the individual stools together\]/Dose) and D duodenal, total is defined as total percentage of the dose collected in all duodenal samples collectively, calculated as % of dose.

Metabolic profiles of JNJ-53718678 in plasma, duodenal fluid, urine, and feces samples with radio high-performance liquid chromatography analysis
Up to Day 6

Metabolite profiling will be performed with radio high-performance liquid chromatography.

Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678
Up to 72 hour of Post-dose

The Cmax is the maximum observed plasma concentration.

Area Under the Plasma ConcentrationTime Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0last]) of JNJ-53718678
Up to 72 hour of Post-dose

The AUC (0-last) is the area under the plasma concentration time curve from time 0 to the time of the last measurable non-below quantification limit concentration, calculated by liner-linear trapezoidal summation.

Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-53718678
Up to 72 hour of Post-dose

The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Relative Bioavailability of JNJ-53718678
Up to 72 hour of Post-dose

The relative bioavailability based on Cmax, AUC(0last), and AUC(0-inf) will be estimated as 100\*Test/Reference, where Test is defined as the pharmacokinetic parameters of oral JNJ-53718678 and Reference is defined as currently existing oral solution G024.

Effect of Food on the Bioavailabilty of JNJ-53718678
Up to 72 hour of Post-dose

The effect of food will be evaluated by comparing the pharmacokinetics of JNJ-53718678 under fed conditions with the currently existing oral solution under fasted conditions.

Maximum Observed Analyte Concentration (Cmax)
Up to 11 days

The Cmax is the maximum observed analyte concentration after the JNJ-53718678 doses on Day 1, Day 4 (Panel 2 only) and Day 9.

Area Under the Analyte Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC [0-last])
Up to 11 days

The (AUC \[0-last\]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration after the JNJ-53718678 doses on Day 1 and Day 9.

Area Under the Analyte Concentration-Time Curve From Time 0 to Infinite Time (AUC [0-infinity])
Up to 11 days

The AUC (0-infinity) is the area under the Analyte concentration-time curve from time 0 to infinite time after the JNJ-53718678 doses on Day 1 and Day 9, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

Area Under the Analyte Concentration-time curve From Time 0 to 24h (AUC24h)
Up to 11 days

The AUC24h is the area under the analyte concentration-time curve from time 0 to 24h after dosing on Day 1 and Day 4 (Panel 2 only).

Ratio of Individual Cmax Values Between Test and Reference Treatment (Ratio Cmax, test/reference)
Up to 11 days

Ratio Cmax, test/reference is the ratio of individual Cmax values between test (JNJ-53718678 with itraconazole, on Day 9, or JNJ-53718678 with rifampicin, on Day 4 and Day 9) and reference (without itraconazole or rifampicin, on Day 1) treatments.

Ratio of Individual AUC24h Values Between Test and Reference Treatment (Ratio AUC24h, test/reference)
Up to 11 days

Ratio AUC24h, test/reference is the ratio of individual AUC24h values between test (JNJ-53718678 with rifampicin, on Day 4) and reference (without rifampicin, on Day 1) treatments.

Ratio of Individual AUClast Values Between Test and Reference Treatment (Ratio AUClast, test/reference)
Up to 11 days

Ratio AUClast, test/reference is the ratio of individual AUClast values between test (JNJ-53718678 with itraconazole or rifampicin, on Day 9) and reference (without itraconazole or rifampicin, on Day 1) treatments.

Ratio of Individual AUC(infinity) Values Between Test and Reference Treatment (Ratio AUC[infinity], test/reference)
Up to 11 days

Ratio AUC(infinity), test/reference is the ratio of individual AUC(infinity) values between test (JNJ-53718678 with itraconazole or rifampicin, on Day 9) and reference (without itraconazole or rifampicin, on Day 1) treatments.

Maximum Observed Plasma Concentration (Cmax)
Up to 72 hours post dose

The Cmax is the maximum observed plasma concentration.

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Up to 72 hours post dose

The Tmax is defined as actual sampling time to reach maximum observed JNJ 53718678 concentration.

Time to Last Quantifiable Plasma Concentration (Tlast)
Up to 72 hours post dose

The Tlast is the time to last observed quantifiable plasma concentration.

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Up to 72 hours post dose

The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Up to 72 hours post dose

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Apparent Initial Elimination Rate Constant (lambda [alpha])
Up to 72 hours post dose

Apparent initial elimination rate constant, determined by linear regression of the data points within the first elimination phase of the ln-linear plasma concentration-time curve.

Elimination Rate Constant (Lambda[z])
Up to 72 hours post dose

Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

Apparent Initial Elimination Half-life (t1/2[alpha])
Up to 72 hours post dose

Apparent initial elimination half-life is calculated as 0.693/lambda(alpha).

Elimination Half-Life (t1/2)
Up to 72 hours post dose

The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

Total Apparent Clearance (CL/F)
Up to 72 hours post dose

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Apparent Volume of Distribution (Vd/F)
Up to 72 hours post dose

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vd/F) is influenced by the fraction absorbed.

Number of Participants With Adverse Events
From sign of informed consent up to end of study (Day 14)

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.

Secondary Endpoints

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to Day 28
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
Up to Day 28
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
Up to Day 28
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment A: JNJ-53718678 500 mgEXPERIMENTALParticipants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.
Treatment B: JNJ-53718678 80 mg + PlaceboEXPERIMENTALParticipants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Treatment C: PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Cohort 1EXPERIMENTALParticipants will receive placebo or JNJ-53718678 500 milligram (mg) or 200 mg once daily for 7 days.
Cohort 2EXPERIMENTALParticipants will receive placebo or JNJ-53718678; dosing regimen in Cohort 2 will be decided based on Cohort 1 results.
Cohort 3EXPERIMENTALParticipants will receive placebo or JNJ-53718678, 75 mg once daily for 7 days.
Treatment Sequence 1: Treatment ABCEXPERIMENTALParticipants will receive Treatment A (JNJ-53718678 once daily for 7 days) in Treatment Period 1, followed by Treatment B (JNJ-64417184 once daily for 7 days) in Treatment Period 2, followed by Treatment C (JNJ-53718678 once daily + JNJ-64417184 once daily for 7 days) in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.
Treatment Sequence 2: Treatment BCAEXPERIMENTALParticipants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.
Treatment Sequence 3: Treatment CABEXPERIMENTALParticipants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment B in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.
Treatment Sequence 4: Treatment ACBEXPERIMENTALParticipants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment B in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.
Treatment Sequence 5: Treatment BACEXPERIMENTALParticipants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.
Treatment Sequence 6: Treatment CBAEXPERIMENTALParticipants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment A in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods.
Part 1 (Dose Escalation): Panel 1EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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 3EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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 EHFGEXPERIMENTALParticipants 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 FEGHEXPERIMENTALParticipants 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 GFHEEXPERIMENTALParticipants 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 HGEFEXPERIMENTALParticipants 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.
JNJ-53718678EXPERIMENTAL -
JNJ-53718678: PART 1EXPERIMENTALParticipants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and B (novel concept formulation 1), and under fed condition for treatment C (novel concept formulation 1).
JNJ-53718678: PART 2EXPERIMENTALParticipants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and D (novel concept formulation 2), and under fed condition for treatment E (novel concept formulation 2). Part 2 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 3EXPERIMENTALParticipants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and F (novel concept formulation 3), and under fed condition for treatment G (novel concept formulation 3). Part 3 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 4EXPERIMENTALParticipants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and H (novel concept formulation 4), and under fed condition for treatment I (novel concept formulation 4). Part 4 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 5EXPERIMENTALParticipants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and J (novel concept formulation 5), and under fed condition for treatment K (novel concept formulation 5). Part 5 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 6EXPERIMENTALParticipants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and L (novel concept formulation 6), and under fed condition for treatment M (novel concept formulation 6). Part 6 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 7EXPERIMENTALParticipants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and N (novel concept formulation 7), and under fed condition for treatment O (novel concept formulation 7). Part 7 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.
JNJ-53718678: PART 8EXPERIMENTALParticipants will receive a single dose of JNJ-53718678, 500 mg oral solution under fasted or fed conditions on day 1 for treatment A and P (oral concept formulation 1, 2, 3, 4, 5, 6 or 7) and under fed conditions for treatment Q (oral concept formulation 1, 2, 3, 4, 5, 6 or 7). Part 8 of the study is optional, might be performed, depending on the interim results of prior parts. One of the concept formulations might be re-evaluated under different feeding conditions.
Panel 1EXPERIMENTALParticipants will receive a single 250 milligram (mg) dose of JNJ-53718678 on Day 1 and 200 mg itraconazole once a day on Days 4 to 11 along with a single 250-mg dose of JNJ-53718678 on Day 9.
Panel 2EXPERIMENTALParticipants will receive a single 500-mg dose of JNJ-53718678 on Day 1; a single 600-mg dose of rifampicin along with a single 500-mg dose of JNJ-53718678 on Day 4 and 600 mg rifampicin once daily on Days 5 to 11 along with a single 500-mg dose of JNJ-53718678 on Day 9.
JNJ 53718678 250 milligram (mg)EXPERIMENTALParticipants will receive either single oral dose of 250 mg of JNJ 53718678 or matching placebo on Day 1.
JNJ 53718678 500 mgEXPERIMENTALParticipants will receive either single oral dose of 500 mg of JNJ 53718678 or matching placebo on Day 1.
JNJ 53718678 1000 mgEXPERIMENTALParticipants will receive either single oral dose of 1000 mg of JNJ 53718678 or matching placebo on Day 1.

Interventions

NameTypeDescription
JNJ-53718678 500 mgDRUGParticipants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.
JNJ-53718678 80 mgDRUGParticipants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
PlaceboDRUGIn treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
JNJ-53718678DRUGParticipants will receive JNJ-53718678 as 20 milliliter (mL) (200 mg) or 50 mL (500 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 1. JNJ-53718678 dose in Cohort 2 will be decided based on Cohort 1 results. JNJ-53718678 as 7.5 mL (75 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 3.
JNJ-64417184DRUGJNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
JNJ-53718678, 2000 mgDRUGParticipants will be administered JNJ-53718678, 2000 mg as oral suspension in Part 1 (Panel 1).
JNJ-53718678, 3000 mgDRUGParticipants will be administered JNJ- 53718678, 3000 mg as oral suspension in Part 1 (Panel 2).
JNJ-53718678, 4500 mg or Dose to be decidedDRUGParticipants 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 PlaceboDRUGParticipants will be administered JNJ-53718678 matching placebo in Part 1 and 2.
Moxifloxacin 400 mgDRUGParticipants will be administered moxifloxacin 400 mg as capsule in Part 2.
Moxifloxacin PlaceboDRUGParticipants will be administered moxifloxacin matching placebo in Part 2.
ItraconazoleDRUGParticipants will receive itraconazole 200 mg (2 capsules of 100 mg) from Day 4-11.
RifampicinDRUGParticipants will receive 600 mg rifampicin (2 capsules of 300 mg) from Day 4-11.
JNJ 53718678DRUGJNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites124

Inclusion Criteria: * Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to 5 days from th...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaFranceGermanyJapanMexicoPolandRussiaSouth AfricaSouth KoreaSpainSwedenTaiwanUkraineUnited KingdomNetherlands
Unlock Eligibility Criteria

Frequently asked questions about JNJ-53718678

What is JNJ-53718678 used for?

JNJ-53718678 is an investigational small molecule being studied for respiratory syncytial virus (RSV) infections and in healthy volunteers. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being evaluated for its safety, tolerability, and pharmacokinetics in early-stage trials.

Who makes JNJ-53718678?

JNJ-53718678 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics and drug interactions in healthy participants. All six completed trials were sponsored by Johnson & Johnson.

What phase is JNJ-53718678 in?

JNJ-53718678 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug has completed six Phase 1 trials, with no active trials currently ongoing. These trials focused on healthy volunteers to assess safety and how the drug is processed by the body.

What clinical trials is JNJ-53718678 in?

JNJ-53718678 has completed six Phase 1 trials, including NCT02729467, NCT02945007, NCT03002779, and NCT04090086. These studies assessed drug interactions, bioavailability, food effects, and metabolism in healthy adults. The trials were conducted in the United States, Belgium, and the Netherlands, with a total enrollment of 213 participants.

Is JNJ-53718678 the same as JNJ-64417184?

No, JNJ-53718678 is not the same as JNJ-64417184. They are separate investigational drugs. A completed clinical trial, NCT04090086, studied the interaction between JNJ-64417184 and JNJ-53718678 after single and multiple dosing in healthy participants, indicating they are distinct compounds being evaluated together.