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JNJ-42396302

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Sep 10, 2013

JNJ-42396302 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

JNJ-42396302 clinical trials

JNJ-42396302 · 1 trial · 1 indication

Phase 1 1
NCT01732237A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male ParticipantsHealthy
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants
Healthy
NCT0173223718
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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 to 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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Frequently asked questions about JNJ-42396302

What is JNJ-42396302?

JNJ-42396302 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy male participants. The specific therapeutic indication for JNJ-42396302 has not been disclosed.

Who is developing JNJ-42396302?

JNJ-42396302 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 trial of the compound.

What phase is JNJ-42396302 in?

JNJ-42396302 is in Phase 1 clinical development. One Phase 1 trial has been completed. There are no active trials of JNJ-42396302 at this time.

What clinical trials is JNJ-42396302 in?

JNJ-42396302 has been evaluated in one completed Phase 1 trial, NCT01732237, titled A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants. The trial enrolled 18 healthy male volunteers and was controlled.

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