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JNJ-42396302

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Sep 10, 2013

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01732237A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male ParticipantsPHASE1 COMPLETED 18 — — Aug 1, 2012Oct 1, 2012Sep 10, 2013 - —
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Study Endpoints
Primary Endpoints
Maximum observed plasma analyte concentration (Cmax) of JNJ-42396302
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-42396302
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42396302
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-42396302
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Maximum observed plasma analyte concentration (Cmax) of JNJ-53773187
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-53773187
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-53773187
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-53773187
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Maximum observed plasma analyte concentration (Cmax) of JNJ-42692507
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-42692507
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42692507
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-42692507
10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Secondary Endpoints
Number of patients with adverse events
within 7 days after the last dose of the study medication
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-42396302EXPERIMENTALPatients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
JNJ-42692507EXPERIMENTALPatients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
JNJ-53773187EXPERIMENTALPatients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
Interventions
NameTypeDescription
JNJ-42396302DRUGA single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
JNJ-42692507DRUGA single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
JNJ-53773187DRUGA single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Participant should be healthy male on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis * Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2 * Have a blood pres...

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