Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01559272 | A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia | PHASE1 | COMPLETED | 328 | — | — | Feb 21, 2008 | May 24, 2014 | Sep 18, 2017 | 36 | United States, Belgium +9 |
| 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...