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JNJ-64417184

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Feb 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials4
Total Enrollment198
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04258189A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy ParticipantsPHASE1 COMPLETED 16Feb 11, 2020Aug 5, 2020Feb 3, 20251 Belgium
NCT04208373A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult ParticipantsPHASE1 COMPLETED 32Dec 20, 2019Mar 10, 2020Feb 3, 20251 Belgium
NCT04121052A Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administered as TabletsPHASE1 COMPLETED 20Oct 8, 2019Dec 23, 2019Jan 28, 20201 Netherlands
NCT03403348A First-In-Human Study of Orally Administered JNJ-64417184 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in a Respiratory Syncytial Virus (RSV) Challenge Study in Healthy ParticipantsPHASE1 COMPLETED 130May 9, 2018Nov 24, 2019Jan 29, 20202 United Kingdom
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184
Up to Day 6

Cmax is the maximum observed plasma analyte concentration.

Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-64417184
Up to Day 6

AUC (0-last) is area under the plasma analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.

Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-64417184
Up to Day 6

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

Maximum Observed Plasma Analyte concentration (Cmax) of JNJ 64417184
Predose up to 144 hours post dose

Cmax is defined as maximum observed plasma analyte.

Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ 64417184
Predose up to 144 hours post dose

AUC (0-last) is defined as the area under the plasma analyte concentration- time curve (AUC) from time 0 to the time of the last measurable (non-below qualification limit) concentration.

Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ 64417184
Predose up to 144 hours post dose

AUC (0-infinity) is defined as AUC from time 0 to infinite time, calculated as the sum of AUC(0-last) and C(last)/ lambda(z), wherein C(last) is the last observed quantifiable concentration; extrapolations of more than 20 percent (%) of the total AUC.

Plasma Concentration of JNJ-64417184 under Fasted and Fed (Low-fat meal, Ensure Original, Standard meal, and High-Fat Meal as a Reference) Conditions
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose

Plasma concentration of JNJ-64417184 under fasted and fed (low-fat meal, Ensure Original, standard meal, and high-fat meal as a reference) conditions will be determined.

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Approximately up to 8 months

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Number of Participants With Laboratory Abnormalities
Approximately up to 8 months

Number of participants with laboratory abnormalities will be reported.

Number of Participants With Clinically Significant Changes in Vital Signs
Approximately up to 8 months

Number of participants with clinically significant changes in vital signs will be reported.

Number of Participants With Clinically Significant Changes in Physical Examination Findings
Approximately up to 8 months

Number of participants with clinically significant changes in physical examination findings will be reported.

Number of Participants With ECG Abnormalities
Approximately up to 8 months

Number of participants with electrocardiogram (ECG) abnormalities will be reported.

Change From Baseline in QT Interval Corrected According to Fridericia's Formula (QTcF) (Parts 1 and 3)
Baseline up to Day 31

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

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Absolute as Measured by Spirometry (Part 4)
Baseline up to Day 31

FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in absolute FEV1 indicates improvement in lung function.

Change From Baseline in Forced Vital Capacity (FVC) Absolute as Measured by Spirometry (Part 4)
Baseline up to Day 31

FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, in liters and will be measured by spirometry.

Change From Baseline in Percent-Predicted FEV1 (Part 4)
Baseline up to Day 31

FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests will be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100 percent (%).

Change From Baseline in Percent-Predicted FVC (Part 4)
Baseline up to Day 31

Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100 %.

Area Under the Concentration-Time Curve Between Time of First Administration and Dosing Day 7 (AUC[0-Dosing Day 7]) of RSV-A Memphis 37b Viral Load in Participants Infected Through Inoculation With This Viral Strain (Part 4)
Up to Day 7

Area under the concentration-time curve between time of first administration and Dosing Day 7 (AUC\[0-Dosing Day 7)\] of respiratory syncytial virus (RSV)-A Memphis 37b viral load in participants infected through inoculation with this viral strain, as determined by a quantitative real-time polymerase chain reaction (qRT PCR) assay of nasal wash (Part 4) will be assessed.

Secondary Endpoints
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to 28 days
Acceptability of the JNJ-64417184 Formulation as Assessed by Participant
Up to 28 days
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Up to 54 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Panel 1: Treatment Sequence ABDCEXPERIMENTALParticipants will receive Treatment A (a single dose of JNJ-64417184 \[oral solution with preservatives\] in fasted condition) in treatment Period 1; followed by Treatment B (a single dose of JNJ-64417184 \[oral solution with preservatives\] in fed \[high-fat meal\] condition) in treatment Period 2; followed by Treatment D (a single dose of JNJ-64417184 \[oral solution without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 3, followed by Treatment C (a single dose of JNJ-64417184 \[oral solution without preservatives\] in fasted condition) in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Panel 1: Treatment Sequence BCADEXPERIMENTALParticipants will receive Treatment B in treatment Period 1; followed by Treatment C in treatment Period 2; followed by Treatment A in treatment Period 3, followed by Treatment D in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Panel 1: Treatment Sequence CDBAEXPERIMENTALParticipants will receive Treatment C in treatment Period 1; followed by Treatment D in treatment Period 2; followed by Treatment B in treatment Period 3, followed by Treatment A in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Panel 1: Treatment Sequence DACBEXPERIMENTALParticipants will receive Treatment D in treatment Period 1; followed by Treatment A in treatment Period 2; followed by Treatment C in treatment Period 3, followed by Treatment B in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Optional Panel 2: Treatment Sequence EFGEXPERIMENTALParticipants will receive Treatment E (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fasted condition) in treatment Period 1; followed by Treatment F (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 2; followed by Treatment G (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Optional Panel 2: Treatment Sequence FGEEXPERIMENTALParticipants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Optional Panel 2: Treatment Sequence GEFEXPERIMENTALParticipants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Optional Panel 2: Treatment Sequence GFEEXPERIMENTALParticipants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Optional Panel 2: Treatment Sequence EGFEXPERIMENTALParticipants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Optional Panel 2: Treatment Sequence FEGEXPERIMENTALParticipants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
Panel 1: JNJ 64417184 plus ItraconazoleEXPERIMENTALParticipants will receive single oral dose of JNJ 64417184 on Day 1 followed by itraconazole once daily on Days 6 to 13 along with a single dose of JNJ 64417184 on Day 9 orally.
Panel 2: JNJ 64417184 plus EtravirineEXPERIMENTALParticipants will receive single oral dose of JNJ-64417184 on Day 1 followed by etravirine twice daily on Days 6 to 19 along with single dose of JNJ 64417184 on Day 15.
Treatment Sequence 1EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 2EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 3EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 4EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 5EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 6EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 7EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 1; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 8EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet under fasted condition in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 9EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 10EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 11EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 1; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 12EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet under fasted condition in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions ( low-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 13EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 2; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 14EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 15EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 1; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Treatment Sequence 16EXPERIMENTALParticipants will receive JNJ-64417184 oral tablet under fasted condition in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Part 1: Single Ascending Dose (SAD)EXPERIMENTALParticipants will be enrolled in 7 cohorts and receive one of the 7 corresponding SADs of JNJ-64417184, starting from 40 milligram (mg), or placebo in a fasted state. Dose escalation in the subsequent cohorts will depend on the human maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) in previous cohorts.
Part 2A: Food EffectEXPERIMENTALParticipants enrolled in cohort 4 of part 1 will roll-over in Part 2A and will receive a single oral dose (the same dose as received in Part 1) of JNJ-64417184 or placebo with a high-fat meal.
Part 2B: Relative Bioavailability (Optional)EXPERIMENTALParticipants enrolled in cohorts 5, 6, 7 or any other optional cohorts of Part 1 will roll-over in Part 2B and will receive a single oral dose (the same dose as received in Part 1) of JNJ-64417184 or placebo under fasted state. Dosing may be changed from fasted to a fed state, depending on emerging pharmacokinetics (PK) data from Part 2A.
Part 3: Multiple Ascending Dose (MAD)EXPERIMENTALParticipants will be enrolled in 3 cohorts and will receive one of the 3 corresponding MADs of JNJ-64417184 or placebo, dosed once daily for 7 days. There will be 3 optional cohorts and participants in these cohorts will follow 7- to 14-day dosing schedule. Dosing will either occur in the fasted or the fed state, depending on the outcome of Part 2A. Dose selection and dose escalation in the MAD cohorts will depend on the observed human Cmax and AUC in previous (SAD) cohorts. Additional cohorts may be evaluated at the discretion of the Sponsor and the Principal Investigator (PI).
Part 4: Human RSV Challenge (Proof-of-Concept Study Part)EXPERIMENTALBased on emerging PK and safety data from Part 3 (MAD), the participants inoculated with respiratory syncytial virus (RSV) -A Memphis 37b and confirmed positive by polymerase chain reaction (PCR) will either receive JNJ-64417184 or placebo once daily OR receive JNJ-64417184 (low dose), JNJ-64417184 (high dose) or placebo once daily.
Part 5: SAD/JapaneseEXPERIMENTALParticipants of Japanese descent will be enrolled in 3 cohorts and will receive one of the corresponding SADs of JNJ-64417184 or placebo in a fasted state. Dosing may be changed from fasted to a fed state, depending on emerging PK data from Part 2A. The starting dose and formulation will be selected based on the outcome of Parts 1 and 2. Dose escalation in the subsequent cohorts will depend on the observed human Cmax and AUC in previous cohorts.
Part 6: MAD/Japanese (Optional)EXPERIMENTALParticipants of Japanese descent may be enrolled in 3 cohorts and will receive one of the corresponding MADs of JNJ-64417184 or placebo, dosed once daily for 7 to 14 days. Dosing will either occur in the fasted or the fed state, depending on the outcome of Part 2A. Dose selection and dose escalation in the MAD cohorts will depend on the observed human Cmax and AUC in previous (Parts 1, 2, 3, and 5) cohorts.
Interventions
NameTypeDescription
JNJ-64417184DRUGSingle dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.
ItraconazoleDRUGItraconazole capsules will be administered orally
EtravirineDRUGetravirine tables will be administered orally.
PlaceboDRUGParticipants will receive matching placebo to JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must have a body mass index (BMI; weight \[kg\]/height\^2 \[m\^2\]) between 18.0 and 30.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg at screening * Healthy on the basis of physical examination, medical and surgical history, ...

Countries:BelgiumNetherlandsUnited Kingdom
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