Phase 2
Completed N=81
Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
Source: ClinicalTrials.gov NCT01348100 ↗Enrolled (actual)
81
Serious AEs
1.9%
Results posted
Oct 2013
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Iloperidone Divided by the Average Plasma Concentration (Cav) of Iloperidone (Cmax/Cav) - Phase B — 1.91; 1.87 Ratio of Cmax to Cav
Summary
This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected for assessment in Phase C. Phase C of this study is designed to define the dose-exposure relationship of the selected form and to provide information that will permit a comparison of the risk-benefit ratio of several doses of the study drug to enable optimal dose selection for later studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Iloperidone Divided by the Average Plasma Concentration (Cav) of Iloperidone (Cmax/Cav) - Phase B |
1.91; 1.87 | — |
| PRIMARY The Average Plasma Concentration (Cav) of Iloperidone - Phase C |
3.73; 7.93; 11.8; 4.52; 10.1; 16.0 | — |
| SECONDARY Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase B |
48.1; 168 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase B |
6.25; 8.40 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase B |
2310; 3190 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) of Iloperidone - Phase B |
2890; 3730 | — |
| SECONDARY The Average Plasma Concentration (Cav) of Iloperidone - Phase B |
3.44; 4.74 | — |
| SECONDARY Duration That the Concentration of Iloperidone Was Above 4 ng/mL (Teff) - Phase B |
150; 365 | — |
| SECONDARY Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase C |
48; 227; 192; 48; 207; 195 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase C |
6.45; 15.2; 19.7; 8.15; 21.6; 29.2 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase C |
2500; 5330; 7930; 3040; 6820; 10700 | — |
| SECONDARY The Average Plasma Concentration (Cav) of Iloperidone Divided by Dose - Phase C |
0.0156; 0.0172; 0.0196; 0.0300; 0.0242; 0.0328 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with schizophrenia that have been stable for 3 months.
Exclusion Criteria
- Women who can become or are currently pregnant or lactating.
- Hypersensitivity to iloperidone or related drugs.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01348100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.