Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Paliperidone IR is an investigational small molecule being studied for the treatment of schizophrenia. It is in Phase 1 clinical development. The drug is being evaluated in patients with schizophrenia to assess its pharmacokinetics, safety, and tolerability.
Paliperidone IR is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this drug for the treatment of schizophrenia.
Paliperidone IR is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed to evaluate the drug in patients with schizophrenia.
Paliperidone IR has one completed clinical trial, identified as NCT01559272. This Phase 1 study assessed the pharmacokinetics, safety, and tolerability of paliperidone palmitate in 328 patients with schizophrenia. The trial was conducted across multiple countries, including the United States, Belgium, Bulgaria, Croatia, Israel, Malaysia, Slovakia, South Africa, South Korea, Spain, and Taiwan.
Paliperidone IR is related to paliperidone palmitate, as the clinical trial NCT01559272 evaluated paliperidone palmitate in patients with schizophrenia. The study was designed to assess the pharmacokinetics, safety, and tolerability of this formulation. Paliperidone IR itself is an immediate-release formulation of paliperidone.