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JNJ-56021927 60 Milligram

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Jan 11, 2017

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
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02835508Pharmacokinetic Study of JNJ-56021927 When Taken Orally as Tablet Formulation in Healthy Male Japanese ParticipantsPHASE1 COMPLETED 18Jun 1, 2016Dec 1, 2016Jan 11, 20171 Japan
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Predose, Up to Day 57

Maximum observed plasma concentration (Cmax) will be assessed.

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Predose, Up to Day 57

Actual sampling time to reach maximum observed analyte concentration (Tmax) will be assessed.

Area Under Concentration from time zero to the last quantifiable AUC (0-last)
Predose, Up to Day 57

AUC from time zero to the last quantifiable concentration will be assessed.

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Predose, Up to Day 57

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 (0-last) and C (0-last)/lambda(z); wherein AUC (0-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. AUC (0-infinity) will be assessed.

Time to Last Quantifiable Plasma Concentration (Tlast)
Predose, Up to Day 57

The Tlast, time to last observed quantifiable plasma concentration will be assessed.

Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC,ext)
Predose, Up to Day 57

Percentage of area under the plasma concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC,ext) is calculated as (AUC \[0-infinity\] minus AUC \[0-last\])/ AUC \[0-infinity\])\*100.

Apparent Clearance (CL/F)
Predose, Up to Day 57

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. CL/F will be calculated as CL/F = Dose/AUC \[0-infinity\]

Apparent Terminal Elimination Half-life (t1/2term)
Predose, Up to Day 57

Apparent terminal elimination half-life, calculated as 0.693/apparent terminal elimination rate constant (λz)

Apparent Terminal Elimination Rate Constant (lambda z)
Predose, Up to Day 57

Apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data

Apparent Volume of Distribution (Vd/F)
Predose, Up to Day 57

Apparent volume of distribution based on the terminal phase following oral administration calculated as Vd/F = Dose/ apparent terminal elimination rate constant (λz)\*AUC \[0-infinity\]

Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
Predose, Up to Day 57

Metabolite to parent drug ratio for Cmax will be assessed.

Metabolite to Parent Drug Ratio for Area Under Concentration from time zero to the last quantifiable concentration (MPR AUC [0-last])
Predose, Up to Day 57

Metabolite to parent drug ratio for AUC \[0-last\] will be assessed.

Metabolite to Parent Drug Ratio for Area Under Curve from time zero extrapolated to infinity (MPR AUC [0-infinity])
Predose, Up to Day 57

Metabolite to parent drug ratio for AUC \[0-infinity\] will be assessed.

Area Under Curve from time of administration to 24 hours post dosing
Predose, Up to Day 57

AUC from time of administration to 24 hours post dosing will be assessed.

Area Under Curve from time of administration to 168 hours post dosing
Predose, Up to Day 57

AUC from time of administration to 168 hours post dosing will be assessed.

Secondary Endpoints
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Up to Day 57
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALParticipants will receive a single dose of 1 tablet of JNJ-56021927, 60 milligram (mg) on Day 1.
Treatment BEXPERIMENTALParticipants will receive a single dose of JNJ-56021927, 120 mg (2 tablets\*60 mg) on Day 1.
Treatment CEXPERIMENTALParticipants will receive a single dose of JNJ-56021927, 240 mg (4 tablets\*60 mg) on Day 1.
Interventions
NameTypeDescription
JNJ-56021927 60 MilligramDRUGJNJ-56021927 60 mg oral tablet.
JNJ-56021927 120 MilligramDRUGJNJ-56021927 120 mg as 2 tablets of 60 mg.
JNJ-56021927 240 MilligramDRUGJNJ-56021927 240 mg as 4 tablets of 60 mg.
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Eligibility Criteria
Age Range20 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant must have a body mass index between 18.0 and 29.9 Kilogram per meter square (kg/m\^2), inclusive, and a body weight not less than 50 Kilogram (kg) * Participant must have a blood pressure between 90 and 140 Millimeters of Mercury (mm Hg) systolic, inclusive, and no...

Countries:Japan
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