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JNJ-63623872

Phase 2

Influenza A Virus | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Mar 27, 2020

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-63623872 · 5 trials · 2 indications

Phase 2 1Phase 1 4
NCT02532283A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A InfectionInfluenza A Virus
COMPLETED102 Analytics
PHASE2COMPLETED
A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection
Influenza A Virus
NCT02532283102
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of Pimodivir
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3

Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to \[\<=\] 85 years and 18 to \<=64 years).

Minimum Observed Plasma Concentration (Cmin) of Pimodivir
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3

Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).

Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3

AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).

Maximum Observed Plasma Concentration (Cmax)
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5

The Plasma Concentration (Cmax) is defined as maximum observed plasma concentration.

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5

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

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration Time (AUC [0-Last])
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5

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

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5

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 Terminal Elimination Rate Constant (Lambda [z])
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5

Lambda (z) is defined as apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration versus time curve.

Apparent Terminal Elimination Half-life (t1/2)
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Maximum Observed Analyte Concentration (Cmax)
Up to 10 days

The Cmax is the maximum observed analyte concentration.

Fluctuation Index (FI)
Up to 10 days

FI is defined as the percentage fluctuation between the Ctrough, morning analyte concentration and the maximum analyte concentration.

Average Analyte Concentration (Cavg)
Up to 10 days

The Cavg is an average analyte concentration at steady-state over the dosing interval.

Time to Reach the Maximum Observed Analyte Concentration (Tmax)
Up to 10 days

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

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to 12 Hour (AUC [0-12])
Up to 10 days

The (AUC \[0-12\]) is the area under the plasma concentration-time curve from time 0 to 12 hour post dose, calculated by linear-linear trapezoidal summation.

Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last])
Up to 10 days

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

Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Up to 10 days

The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(last) and C(last)/lambda(z), where Clast is the last observed measurable (non-BQL) concentration; extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.

Elimination Rate Constant (Lambda[z])
Up to 10 days

Lambda(z) is apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve.

Apparent Terminal Elimination Half-life (t1/2term)
Up to 10 days

Apparent terminal elimination half-life is defined as 0.693/Lambda\[z\].

Systemic Clearance (CL)
Up to 10 days

CL is the total systemic clearance, following intravenous administration.

Apparent Clearance (CL/F)
Up to 10 days

CL/F is the total apparent clearance, following extravascular administration.

Volume of Distribution (Vd)
Up to 10 days

The Vd is defined as volume of distribution, following single dose intravenous administration.

Apparent Volume of Distribution (Vd/F)
Up to 10 days

Vd/F is defined as apparent volume of distribution, following single dose extravascular administration.

Volume of Distribution at Steady-State (Vss)
Up to 10 days

Vss is defined as apparent volume of distribution at steady-state following intravenous administration.

Observed Accumulation Index (RA abs)
Up to 10 days

Observed Accumulation Index is calculated by AUC12h, steady state/(AUC12h, single dose).

Morning Trough Analyte Concentration (Ctrough, morning)
Up to 10 days

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

Evening Trough Analyte Concentration (Ctrough, evening)
Up to 10 days

Ctrough, evening is defined as observed analyte concentration at the end of a dosing interval.

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to End of Study (Day 14)
Maximum Plasma Concentration (Cmax) of JNJ-63623872
Baseline up to Day 8

The Cmax is the maximum plasma concentration.

Time to reach maximum concentration (tmax) of JNJ-63623872
Baseline up to Day 8

The Tmax is time to reach the maximum plasma concentration.

Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last]) of JNJ-63623872
Baseline up to Day 8

AUC from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63623872
Baseline up to Day 8

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; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

Terminal Half-Life(t[1/2]) of JNJ-63623872
Baseline up to Day 8

Terminal half-life (t\[(1/2\]) is defined as 0.693/Lambda(z).

Rate Constant (Lambda[z])
Baseline up to Day 8

Lambda(z) is first-order 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 total body clearance (CL/F) of JNJ-63623872
Baseline up to Day 8

Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity).

Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-63623872
Baseline up to Day 8

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 blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).

Amount of JNJ-63623872 excreted in Urine (Ae[x-y])
Baseline up to Day 8

Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.

Total Amount of JNJ-63623872 excreted in Urine (Ae[total])
Baseline up to Day 8

Total amount excreted into urine, calculated by adding the amounts of the individual intervals together.

Percentage of JNJ-63623872 dose excreted into urine
Baseline up to Day 8

Percentage of the dose excreted into urine of the collection interval x to y hours post dosing, calculated as 100 x (Aex-y/Dose).

Total Percentage of JNJ-63623872 dose excreted into urine
Baseline up to Day 8

Total percentage of the dose excreted into urine, calculated as 100 \* (Ae\[total\]/Dose).

Renal clearance
Baseline up to Day 8

Renal clearance calculated as Ae (total)/AUC (infinity).

Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-63623872
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

The Tmax is the time to reach the maximum observed plasma concentration of JNJ-63623872.

Time of Last Measurable Plasma Concentration (Tlast) of JNJ-63623872
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

Time of last measurable (non-below quantification limit \[non-BQL\]) plasma concentration.

Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of JNJ-63623872
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

The AUC (0-last) is the area under the plasma JNJ-63623872 concentration-time curve from time 0 to time of the last observed (non-BQL) quantifiable concentration, calculated by linear-linear trapezoidal summation.

Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-63623872
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

The AUC (0-infinity) is the area under the plasma JNJ-63623872 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-63623872 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed (non-BQL) quantifiable concentration and lambda(z) is elimination rate constant. Extrapolations of more than 20.00% of the total AUC are reported as approximations.

Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

The %AUC\[infinity,ex\] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC\[0-infinity\] - AUC\[0-last\])\*100/AUC\[0-infinity\].

Elimination Rate Constant (Lambda [z]) of JNJ-63623872
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.

Apparent Terminal Half-life (t[1/2]) of JNJ-63623872
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

The t(1/2) is defined as 0.693/Lambda (z).

Total Apparent Clearance (CL/F) of JNJ-63623872
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

The CL/F is defined as Dose/AUC (0-infinity).

Apparent Volume of Distribution (Vd/F) of JNJ-63623872
Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

The Vd/F is defined as Dose/\[Lambda (z)\*AUC (0-infinity)\].

Secondary Endpoints

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
Up to 28 Days
Time to Influenza A Viral Negativity
Up to 14 Days
Influenza Viral Load Over Time
Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-63623872 plus OseltamivirEXPERIMENTALParticipants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Placebo plus OseltamivirEXPERIMENTALParticipants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Panel 1: Group 1EXPERIMENTALParticipants will receive Treatment A (JNJ-63623872 600 milligram (mg) (2\*300 mg) oral tablets \[reference\]) followed by Treatment B (JNJ- 63623872 600 mg (2\*300 mg) concept oral tablet formulation 1 (test 1) and then Treatment C (JNJ-63623872 600 mg (2\*300 mg) concept oral tablet formulation 2 (test 2). Each treatment period will be separated 7 days washout period.
Panel 1: Group 2EXPERIMENTALParticipants in Group 2 will receive Treatment A followed by Treatment C and then Treatment B with a washout period of minimum 7 days.
Panel 1: Group 3EXPERIMENTALParticipants in Group 3 will receive Treatment B followed by Treatment A and then Treatment C with a washout period of minimum 7 days.
Panel 1: Group 4EXPERIMENTALParticipants in Group 4 will receive Treatment B followed by Treatment C and then Treatment A with a washout period of minimum 7 days.
Panel 1: Group 5EXPERIMENTALParticipants in Group 5 will receive Treatment C followed by Treatment A and then Treatment B with a washout period of minimum 7 days.
Panel 1: Group 6EXPERIMENTALParticipants in Group 6 will receive Treatment C followed by Treatment B and then Treatment A with a washout period of minimum 7 days.
Panel 2: Group 7EXPERIMENTALParticipants in Group 7 will receive Treatment D \[JNJ-63623872/37.5 mg Oseltamivir oral fixed dose combination (FDC) tablet concept formulation (test 3)\] followed by Treatment E (JNJ-63623872 600 mg, administered as 2\*300 mg and Oseltamivir 75 mg, administered as 1\*75 mg). Both treatment periods will be separated with a minimum of 7 days washout period.
Panel 2: Group 8EXPERIMENTALParticipants in Group 8 will receive Treatment E followed by Treatment D with a washout period of minimum 7 days.
Part 1: Period 1 (JNJ-63623872 100 mg or Placebo)EXPERIMENTALParticipants will receive a single intravenous (IV) infusion of JNJ-63623872 100 milligram (mg) \[3 milligram per milliliters (mg/mL) solution\] (Treatment A) or matching placebo (Treatment D) over 120 minutes.
Part 1: Period 2 (JNJ-63623872 200 mg or Placebo)EXPERIMENTALParticipants will receive a single IV infusion of JNJ-63623872 200 mg (3 mg/mL solution) (Treatment B) or matching placebo (Treatment D) over 120 minutes.
Part 1: Period 3 (JNJ-63623872 300 mg or Placebo)EXPERIMENTALParticipants will receive a single IV infusion of JNJ-63623872 300 mg (3 mg/mL solution) (Treatment C) or matching placebo (Treatment D) over 120 minutes.
Part 2: Group 1 (EFG)EXPERIMENTALParticipants will receive a single IV 300-mg infusion of JNJ-63623872 (3 mg/mL solution) over x minutes (Treatment E) followed by a single IV 300-mg infusion of JNJ-63623872 (3 mg/mL solution) over y minutes (Treatment F), then a single oral 600-mg dose (2\* 300 mg tablets) of JNJ-63623872 under fasted conditions (Treatment G). Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days.
Part 2: Group 2 (FGE)EXPERIMENTALParticipants will receive Treatment F, then Treatment G followed by Treatment E. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days.
Part 2: Group 3 (GEF)EXPERIMENTALParticipants will receive Treatment G, then Treatment E followed by Treatment F. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days.
Part 2: Group 4 (GFE)EXPERIMENTALParticipants will receive Treatment G, then Treatment F, followed by Treatment E. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days.
Part 2: Group 5 (FEG)EXPERIMENTALParticipants will receive Treatment F, then Treatment E followed by Treatment G. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days.
Part 2: Group 6 (EGF)EXPERIMENTALParticipants will receive Treatment E, then Treatment G followed by Treatment F. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days.
Part 3: JNJ-63623872 300 mgEXPERIMENTALParticipants will receive multiple IV infusions of JNJ-63623872 300 mg (3 mg/mL) solution every 12 hours on Days 1 to 10, with only a morning dose on Day 10. Duration of infusion and dose will be selected after Part 2 of this study is completed.
JNJ-63623872EXPERIMENTALParticipants will receive a single 600-milligram (mg) dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.
JNJ-63623872 (300 mg) or PlaceboEXPERIMENTALParticipants will receive JNJ-63623872 300 milligram (mg) or placebo tablet orally once on Day 1 under fasted conditions.
JNJ-63623872 (600 mg) or PlaceboEXPERIMENTALParticipants will receive JNJ-63623872 600 mg (2\*300 mg) or placebo tablet orally once on Day 1 under fasted conditions.
JNJ-63623872 (1200 mg) or PlaceboEXPERIMENTALParticipants will receive JNJ-63623872 1200 mg (4\*300 mg) or placebo tablet orally once on Day 1 under fasted conditions.

Interventions

NameTypeDescription
JNJ-63623872DRUGParticipants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.
PlaceboDRUGParticipants will be administered placebo tablets orally twice daily for 7 days.
OseltamivirDRUGParticipants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
JNJ-63623872 (300 mg)DRUGParticipants will receive JNJ-63623872 300 mg tablet orally once on Day 1 under fasted conditions.
JNJ-63623872 (600 mg)DRUGParticipants will receive JNJ-63623872 600 mg (2\*300 mg) tablet orally once on Day 1 under fasted conditions.
JNJ-63623872 (1200 mg)DRUGParticipants will receive JNJ-63623872 1200 mg (4\*300 mg) tablet orally once on Day 1 under fasted conditions.
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: * Participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection * Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reacti...

Countries:United StatesAustraliaBelgiumBrazilCanadaFranceGermanyHong KongMalaysiaNetherlandsNew ZealandSingaporeSpainSwedenTurkey (Türkiye)United Kingdom
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Frequently asked questions about JNJ-63623872

What is JNJ-63623872 used for?

JNJ-63623872 is an investigational small molecule being studied for the treatment of Influenza A Virus infection. It has been evaluated in clinical trials involving healthy volunteers and hospitalized adult and elderly patients with Influenza A infection, including in combination with oseltamivir.

Who makes JNJ-63623872?

JNJ-63623872 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company has sponsored multiple clinical studies of the drug across different countries.

What phase is JNJ-63623872 in?

JNJ-63623872 is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not approved by regulatory authorities and remains in clinical development. All four completed trials were sponsored by Johnson & Johnson.

What clinical trials has JNJ-63623872 been in?

JNJ-63623872 has been studied in four completed clinical trials. NCT02418559 and NCT02448004 evaluated safety and pharmacokinetics in healthy participants. NCT02532283 assessed the drug with oseltamivir in hospitalized Influenza A patients. NCT03023852 examined the bioavailability of a fixed-dose combination tablet.

How does JNJ-63623872 work?

JNJ-63623872 is a small molecule antiviral drug. It has been studied for its antiviral activity against Influenza A Virus, particularly in combination with oseltamivir in hospitalized patients. The specific molecular target of the drug has not been disclosed in the available trial information.

What is the development status of JNJ-63623872?

JNJ-63623872 has completed four clinical trials with a total enrollment of 141 participants. These trials were randomized, double-blind, and controlled. The drug is not approved and is no longer in active clinical development according to the completed trial records.