Recent Updates
Recently added Catalysts

14C-JNJ-39823277

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Jan 30, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

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
HealthyUnlock trial analytics

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about 14C-JNJ-39823277

What is 14C-JNJ-39823277?

14C-JNJ-39823277 is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug is being studied in healthy male participants to evaluate its absorption, metabolism, and excretion. It is not approved and remains in clinical trials.

What is 14C-JNJ-39823277 used for?

14C-JNJ-39823277 is being studied in healthy volunteers to evaluate its absorption, metabolism, and excretion. It is an investigational small molecule in Phase 1 clinical development. The study is designed to understand how the drug is processed by the body, which is a standard part of early drug development.

Who makes 14C-JNJ-39823277?

14C-JNJ-39823277 is developed by Johnson & Johnson, a pharmaceutical company traded on the NYSE under the ticker JNJ. The drug is currently in Phase 1 clinical development, with one completed trial in healthy male participants.

What phase is 14C-JNJ-39823277 in?

14C-JNJ-39823277 is in Phase 1 clinical development. It is an investigational drug and has not been approved. One Phase 1 trial has been completed, which studied the drug in healthy male participants to evaluate its absorption, metabolism, and excretion.

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

14C-JNJ-39823277 has one completed clinical trial, NCT02049697, titled "A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants." The trial was a Phase 1, uncontrolled study conducted in Belgium with 6 healthy male participants aged 18 years and older.