Recent Updates
Recently added Catalysts

14C-paliperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

14C-paliperidone · 1 trial · 1 indication

Phase 1 1
NCT00796029A Study of Plasma Concentrations, Metabolism and Excretion of 14C-paliperidone After a Single Oral DoseSchizophrenia
COMPLETED5 Analytics
PHASE1COMPLETED
A Study of Plasma Concentrations, Metabolism and Excretion of 14C-paliperidone After a Single Oral Dose
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

To investigate the metabolic pathways of paliperidone and excretion of paliperidone and its metabolites in healthy adult male volunteers,both poor and extensive metabolizers for CYP2D6,after administration of a single 1 mg oral dose of 14C paliperidone

Secondary Endpoints

To evaluate the safety and tolerability of paliperidone, as well as the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and exposure to paliperidone and its metabolites
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
14C-paliperidoneDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to 60 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Dextromethorphan metabolic ratio of \>0.345 (poor metabolizer) or \<0.0255 (extensive metabolizer) * Body Mass Index: (weight \[kg\]/height \[m\]2) between 20 and 28 kg/m2, inclusive * Volunteers must have signed an informed consent document indicating that they understand the...

Unlock Eligibility Criteria

Frequently asked questions about 14C-paliperidone

What is 14C-paliperidone used for in schizophrenia?

14C-paliperidone is an investigational small molecule being studied for use in schizophrenia. It is a radiolabeled form of paliperidone, used in clinical research to track the drug's plasma concentrations, metabolism, and excretion after a single oral dose. It is currently in Phase 1 clinical development.

Who makes 14C-paliperidone?

14C-paliperidone is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is in Phase 1 clinical development for the treatment of schizophrenia.

What phase is 14C-paliperidone in?

14C-paliperidone is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 study has been completed, which evaluated the drug's plasma concentrations, metabolism, and excretion after a single oral dose in healthy male volunteers.

What clinical trials is 14C-paliperidone in?

14C-paliperidone has one completed clinical trial, registered as NCT00796029. The study, titled 'A Study of Plasma Concentrations, Metabolism and Excretion of 14C-paliperidone After a Single Oral Dose,' was a Phase 1, uncontrolled trial that enrolled 5 healthy male volunteers aged 40 years and older.

Is 14C-paliperidone the same as paliperidone?

14C-paliperidone is a radiolabeled form of paliperidone, meaning it contains a radioactive carbon isotope (14C) used to trace the drug's behavior in the body. It is used in research to study how paliperidone is absorbed, metabolized, and excreted, rather than as a therapeutic treatment itself.