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14C-JNJ-39823277

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Jan 30, 2014

14C-JNJ-39823277 development status

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

14C-JNJ-39823277 clinical trials

14C-JNJ-39823277 · 1 trial · 1 indication

Phase 1 1
NCT02049697A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male ParticipantsHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants
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Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax) of 14C-JNJ-39823277 in plasma
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose
Time of observed maximum plasma concentration (Tmax) of 14C-JNJ-39823277
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 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 14C-JNJ-39823277
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 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 14C-JNJ-39823277
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 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 14C-JNJ-39823277
Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose

T1/2 is the time measured for the plasma concentration to decrease by one-half of 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).

Mass Balance After an Oral Dose of 14C-JNJ-39823277 as Generated From Recovery of Total Radioactivity Excreted in Urine and Feces
Predose and up to 168 hours post-dose
Routes of 14C-JNJ-39823277 Elimination Measured Through Total Radioactivity Concentrations in Urine and Feces
Predose and up to 168 hours post-dose
Whole Blood and Plasma Partitioning of Total Radioactivity Through Measurement of Total Radioactivity Levels in Blood
Predose; post-dose 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours
Identification of Major Metabolites in Plasma, Urine, and Feces
Predose and up to 168 hours post-dose

Secondary Endpoints

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

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
14C-JNJ-39823277EXPERIMENTAL -

Interventions

NameTypeDescription
14C-JNJ-39823277DRUGParticipants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution.
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Eligibility Criteria

Age Range18 Years to 56 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) between 20 and 30 kg/m2 (BMI will be calculated as weight \[kg\]/square of height \[square meter\]) * Had consistent bowel movement habit (approximately once per day) within 30 days before dosing * No clinically significant laboratory and electrocardiogra...

Countries:Belgium
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Frequently asked questions about 14C-JNJ-39823277

What is 14C-JNJ-39823277?

14C-JNJ-39823277 is an investigational small molecule developed by Johnson & Johnson. It is a carbon-14 radiolabeled form of the compound JNJ-39823277, used in a Phase 1 study to evaluate absorption, metabolism, and excretion in healthy male participants. The therapeutic indication has not been disclosed.

Who is developing 14C-JNJ-39823277?

14C-JNJ-39823277 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is an investigational small molecule studied in a single Phase 1 clinical trial conducted in Belgium.

What phase is 14C-JNJ-39823277 in?

14C-JNJ-39823277 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled six healthy male participants and was conducted in Belgium.

What clinical trial is 14C-JNJ-39823277 in?

14C-JNJ-39823277 was evaluated in a single Phase 1 trial, NCT02049697, titled A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants. The trial enrolled six healthy male volunteers in Belgium and has been completed.

What is 14C-JNJ-39823277 used for?

14C-JNJ-39823277 is an investigational compound with no disclosed therapeutic indication. Its only recorded clinical study was a Phase 1 absorption, metabolism, and excretion trial in healthy male participants, not a study in patients with a specific disease.