Clinical trial NCT01348100: Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
Official title: An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Two Iloperidone Depot Formulations Followed by a Dose-ranging Phase of One Selected Formulation in Schizophrenic Patients Given Depot Injections Every 28 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Iloperidone
Depot
Injection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Vanda Pharmaceuticals
First posted: 2011-05-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Iloperidone Divided by the Average Plasma Concentration (Cav) of Iloperidone (Cmax/Cav) - Phase B
timeFrame: Pre-dose to 26 days post-dose
measure: The Average Plasma Concentration (Cav) of Iloperidone - Phase C
timeFrame: Pre-dose to 26 days post-dose
Secondary outcomes:
measure: Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase B
timeFrame: Pre-dose to 26 days post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase B
timeFrame: Pre-dose to 26 days post-dose
measure: Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase B
timeFrame: Pre-dose to 26 days post-dose
measure: Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) of Iloperidone - Phase B
timeFrame: Pre-dose to 26 days post-dose
measure: The Average Plasma Concentration (Cav) of Iloperidone - Phase B
timeFrame: Pre-dose to 26 days post-dose
measure: Duration That the Concentration of Iloperidone Was Above 4 ng/mL (Teff) - Phase B
timeFrame: Pre-dose to 26 days post-dose
measure: Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase C
timeFrame: Pre-dose to 26 days post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase C
timeFrame: Pre-dose to 26 days post-dose
measure: Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase C
timeFrame: Pre-dose to 26 days post-dose
measure: The Average Plasma Concentration (Cav) of Iloperidone Divided by Dose - Phase C
timeFrame: Pre-dose to 26 days post-dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Novartis Investigative Site
state: California
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: