Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting
      formulation (in situ microparticle, ISM) of risperidone over four IM injections in the
      gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients
      with schizophrenia.
    

Detailed description: 
      This was a multicenter, open-label, two-arm, parallel-design, repeat-dose clinical study
      designed to evaluate the PK, safety, and tolerability of Risperidone ISM®, a new long-acting
      injectable formulation of the licensed drug risperidone, administered in the gluteal muscle
      or the deltoid muscle. Participants were patients with a diagnosis of schizophrenia capable
      of understanding, signing, and consenting to study participation on their own.

      Objectives:

      Primary Objective

      • To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting
      formulation of risperidone over four IM injections in the gluteal and deltoid muscle at 28
      day intervals and at one dose strength (75 mg) in patients with schizophrenia.

      Secondary Objectives

        -  To document the attainment of steady-state exposure by the injectable formulation ISM®
           of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day
           intervals and at one dose strength (75 mg) in patients with schizophrenia.

        -  To perform a descriptive comparison of the PK data between the gluteal and the deltoid
           muscle administration of the injectable formulation ISM® of risperidone over four IM
           injections at 28-day intervals and at one dose strength (75 mg) in patients with
           schizophrenia.

        -  To evaluate the safety and tolerability of the injectable formulation ISM® of
           risperidone after four IM injections in the gluteal muscle or deltoid muscle at 28-day
           intervals at one dose strength (75 mg) in patients with schizophrenia.

      Exploratory Objectives

        -  To explore the efficacy of once every four weeks of the injectable formulation ISM® of
           risperidone after four IM injections in the gluteal muscle or deltoid muscle at 28-day
           (± 1 day) intervals at one dose strength (75 mg) in patients with schizophrenia.

        -  To characterize patients' metabolic phenotype (cytochrome P450 [CYP]2D6, CYP3A4) to
           explain any potential unexpected outlying PK value, and/or explore its relationship with
           any potential safety or tolerability issue.
    

Intervention name(s): Risperidone ISM
Intervention type(s): Drug
Intervention description(s): Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
Other intervention name(s): No other names
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment