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JNJ-39823277

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Jun 25, 2014

JNJ-39823277 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2014

JNJ-39823277 target and mechanism

ModalitySmall molecule

Also known as TPI-1062

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

JNJ-39823277 clinical trials

JNJ-39823277 · 1 trial · 1 indication

Phase 1 1
NCT02103985A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy ParticipantsHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Participants
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of JNJ-39823277
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

The Cmax is defined as maximum observed analyte concentration.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-39823277
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

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

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-39823277
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

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

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-39823277
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.

Elimination Half-Life Period (T1/2) of JNJ-39823277
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda\[z\]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

Maximum Observed Plasma Concentration (Cmax) of JNJ-40917006 (MC5 metabolite)
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

The Cmax is defined as maximum observed analyte concentration.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-40917006 (MC5 metabolite)
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

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

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-40917006 (MC5 metabolite)
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

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

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-40917006 (MC5 metabolite)
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.

Elimination Half-Life Period (T1/2) of JNJ-40917006 (MC5 metabolite)
Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda\[z\]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

Secondary Endpoints

Number of participants with adverse events as a measure of safety and tolerability
Up to 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALParticipants will receive 100 mg JNJ-39823277 under fed (after a high fat) condition.
Treatment BEXPERIMENTALParticipants will receive 100 mg JNJ-39823277 under fasted condition.

Interventions

NameTypeDescription
JNJ-39823277DRUGParticipants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant must be a healthy male or non-lactating healthy female * Agrees to protocol-defined use of effective contraception * If a woman, must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and on Day -1 of each treatment period * A...

Countries:United States
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Frequently asked questions about JNJ-39823277

What is JNJ-39823277?

JNJ-39823277 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy participants, and no therapeutic indication for the compound has been disclosed. It is not an approved medicine and remains in early clinical development.

Who makes JNJ-39823277?

JNJ-39823277 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound conducted in the United States.

What phase is JNJ-39823277 in?

JNJ-39823277 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials of the compound are currently listed. It is an investigational agent and has not been approved by the FDA for any use.

What clinical trials has JNJ-39823277 been studied in?

JNJ-39823277 has been studied in one clinical trial, NCT02103985, titled A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Participants. The Phase 1 trial enrolled 32 healthy volunteers in the United States, was controlled and randomized, and has been completed.

Is JNJ-39823277 the same as TPI-1062?

Yes. JNJ-39823277 is also known as TPI-1062, and the two names refer to the same investigational small molecule. The alternative name appears in the title of its completed Phase 1 trial, NCT02103985, which evaluated the effect of food on the pharmacokinetics of a single dose in healthy participants.