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Paliperidone IR · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Panel A | EXPERIMENTAL | Panel A consists of 2 treatment groups |
| Panel B | EXPERIMENTAL | Panel B consists of 5 treatment groups |
| Panel C | EXPERIMENTAL | Panel C consists of 1 treatment group |
| Panel D | EXPERIMENTAL | Panel D consists of 4 treatment groups |
| Name | Type | Description |
|---|---|---|
| Paliperidone IR (Period 1) | DRUG | Type= exact number, unit= mg, number=1, form= injection, route= intramuscular use. Single injection with 1 mg paliperidone IR in the gluteal or deltoid muscle. |
| Paliperidone palmitate F015 (Panel A: treatment group 1) | DRUG | Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 manufactured by milling technique A, in the gluteal muscle. |
| Paliperidone palmitate F015 (Panel A: treatment group 2) | DRUG | Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 manufactured by milling technique B, in the gluteal muscle. |
| Paliperidone palmitate F015 (Panel B: treatment group 1) | DRUG | Type= exact number, unit= mg, number= 75, form= injection, route= intramuscular use. Single injection with 75 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle. |
| Paliperidone palmitate F015 (Panel B: treatment group 2) | DRUG | Type= exact number, unit= mg, number=150, form= injection, route= intramuscular use. Single injection with 150 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle. |
| Paliperidone palmitate F015 (Panel B: treatment group 3) | DRUG | Type= exact number, unit= mg, number=450, form= injection, route= intramuscular use. Single injection with 450 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle. |
| Paliperidone palmitate F015 (Panel B: treatment group 4) | DRUG | Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle. |
| Paliperidone palmitate F015 (Panel B: treatment group 5) | DRUG | Type= exact number, unit= mg, number=450, form= injection, route= intramuscular use. Single injection with 450 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle. |
| Paliperidone palmitate F016 | DRUG | Type= exact number, unit= mg, number=150, form= injection, route= intramuscular use. Single injection with 150 mg eq. 3-month formulation paliperidone palmitate F016 in the gluteal muscle. |
| Paliperidone palmitate F015 (Panel D: treatment group 1) | DRUG | Type= exact number, unit= mg, number=525, form= injection, route= intramuscular use. Single injection with 525 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle. |
| Paliperidone palmitate F015 (Panel D: treatment group 2) | DRUG | Type= exact number, unit= mg, number=525, form= injection, route= intramuscular use. Single injection with 525 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle. |
| Paliperidone palmitate F015 (Panel D: treatment group 3) | DRUG | Type= exact number, unit= mg, number=350, form= injection, route= intramuscular use. Single injection with 350 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle. |
| Paliperidone palmitate F015 (Panel D: treatment group 4) | DRUG | Type= exact number, unit= mg, number=175, form= injection, route= intramuscular use. Single injection with 175 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle. |
Inclusion Criteria: * Patients diagnosed with schizophrenia or schizoaffective disorder, for at least 1 year before screening * Clinically stable with no hospitalizations for schizophrenia exacerbation or change in current antipsychotic medications for 3 months prior to screening * Stabilized on an...
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Paliperidone IR is an investigational small molecule being studied for the treatment of schizophrenia. It is an immediate-release form of paliperidone developed by Johnson & Johnson. The clinical program has focused on patients with schizophrenia, with one completed Phase 1 study enrolling 328 participants.
Paliperidone IR targets the serotonin 5-HT2A receptor (HTR2A) and the dopamine D2 receptor (DRD2). It acts as an antagonist at both receptors. This dual antagonism at HTR2A and DRD2 is the mechanism studied in schizophrenia, a condition associated with dopaminergic and serotonergic dysregulation.
Paliperidone IR is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor behind the clinical development program for this immediate-release formulation of paliperidone.
Paliperidone IR is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program includes one completed Phase 1 trial, and no active trials are currently listed for this asset.
Paliperidone IR has been evaluated in one completed Phase 1 trial, NCT01559272, titled A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia. The trial enrolled 328 patients with schizophrenia across the United States, Belgium, Bulgaria, Croatia, Israel, Malaysia, Slovakia, South Africa, South Korea, Spain, and Taiwan.
Yes, Paliperidone IR (Period 1) is an alternative name for Paliperidone IR. Both names refer to the same immediate-release paliperidone asset developed by Johnson & Johnson for schizophrenia, so searches using either name point to the same investigational drug and its single completed Phase 1 study.