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JNJ-49122944, 5 milligram

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Jan 30, 2015

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02280018A Safety, Tolerability and Pharmacokinetics Study of a Single Intravenous Dose of JNJ-49122944 in Healthy Male ParticipantsPHASE1 COMPLETED 12Nov 1, 2014Dec 1, 2014Jan 30, 20151 Belgium
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Throughout the duration of study (up to 4 weeks)

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Maximum Plasma Concentration (Cmax) of JNJ-49122944
Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3

The Cmax is the maximum observed plasma concentration during dosing interval.

Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Time (AUClast) of JNJ-49122944
Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3

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

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-49122944
Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3

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.

Percentage of Area Under the Plasma Concentration-time Curve Obtained by Extrapolation (%AUC [infinity,ex]) of JNJ-49122944
Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3

Percentage of area under the plasma concentration-time curve obtained by extrapolation (%AUC\[inf,ex\]) 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 Half-life (t1/2) of JNJ-49122944
Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3

Elimination half-life (t \[1/2\]) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

Rate Constant (Lambda[z]) of JNJ-49122944
Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3

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 Clearance (CL) of JNJ-49122944
Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3

Apparent clearance of JNJ-49122944 is calculated as Dose/AUC(infinity). The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time.

Apparent Volume of Distribution (Vz) of JNJ-49122944
Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3

Apparent volume of distribution after intravenous administration is calculated as Dose divided by Lambda(z) multiplied by AUC(0-inifinity).

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-49122944, 5 milligram (mg)EXPERIMENTALSingle dose of 5 mg JNJ-49122944, administered as a 22.2 milliliter (mL) intravenous (IV) infusion over 45 minutes in the morning following an overnight fast.
PlaceboPLACEBO_COMPARATORPlacebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes in the morning following an overnight fast.
Interventions
NameTypeDescription
JNJ-49122944, 5 milligram (mg)DRUGParticipants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.
PlaceboDRUGParticipants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male participant, aged 18 to 55 inclusive * Participant 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 * Participant must be deemed healthy on the basis of physical examination, medical hi...

Countries:Belgium
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