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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02087579 | Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants | PHASE1 | COMPLETED | 305 | — | — | Feb 1, 2014 | Dec 1, 2014 | Oct 29, 2015 | 24 | United States, Argentina +5 |
Venous blood samples will be collected at 8 scheduled time points after dosing and compared to fingerstick-based capillary blood samples collected at 6 scheduled time points after dosing.
| Arm | Type | Description |
|---|---|---|
| Cohort A: Aripiprazole | EXPERIMENTAL | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort B: Olanzapine | EXPERIMENTAL | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort C: Paliperidone | EXPERIMENTAL | Administration of prolonged-release (extended-release) tablets or long-acting injectables (LAI) will continue at a participant's usual dose and dosing schedule. |
| Cohort D: Quetiapine | EXPERIMENTAL | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort E: Risperidone | EXPERIMENTAL | Administration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule. |
| Name | Type | Description |
|---|---|---|
| Aripiprazole, oral formulation | DRUG | Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications. |
| Olanzapine, oral formulation | DRUG | Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications. |
| Paliperidone, oral formulation | DRUG | Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
| Paliperidone, LAI | DRUG | Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications. |
| Quetiapine, oral formulation | DRUG | Quetiapine immediate-release (IR) formulation or extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
| Risperidone, oral formulation | DRUG | Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications. |
| Risperidone, LAI | DRUG | Risperidone LAI injections will be administered will be administered per the locally approved label indications. |
Inclusion Criteria: * Must be clinically stable as per the investigator's judgment (no suicidal behavior or current significant suicidal judgment based on C-SSRS rating scale) * No hospitalization for exacerbation of psychiatric symptoms during 3 months before screening * Receiving treatment with a...