Phase 2
N=70
Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02086786 ↗Enrolled (actual)
70
Serious AEs
17.9%
Results posted
Jul 2017
Primary outcome: Primary: Peak Plasma Concentration (Cmax) for Active Moiety — 39.6; 54.1; 53.2; 61.0 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Risperidone ISM (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rovi Pharmaceuticals Laboratories
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration (Cmax) for Active Moiety |
39.6; 54.1; 53.2; 61.0; 48.6; 61.0 | — |
| PRIMARY Trough Plasma Concentration (Cmin) for Active Moiety |
11.1; 7.0; 7.86; 8.60; 9.97; 10.2 | — |
| PRIMARY Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety |
21300; 23300 | — |
| PRIMARY Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety |
21100; 22700 | — |
| PRIMARY AUCτ for Active Moiety |
14100; 16300; 15400; 18000; 16600; 18200 | — |
| PRIMARY Time to Peak Concentration (Tmax) for Active Moiety |
48.0; 48.0; 24.0; 24.0; 48.0; 24.0 | — |
| PRIMARY Terminal Half-life (t1/2) for Active Moiety |
163; 269 | — |
| PRIMARY PTF for Active Moiety |
0.999; 1.76; 1.89; 1.88; 1.39; 1.82 | — |
| SECONDARY Accumulation Ratio (RA) for Active Moiety |
1.15; 1.14 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Capable of providing informed consent.
- Male or female aged ≥18 years to ≤65 years.
- Current diagnosis of schizophrenia, according to Diagnostic and Statistical Manual
- Body mass index (BMI) ≥17 kg/m2 but ≤35 kg/m2.
- Medically stable over the last month, and psychiatrically stable
- On oral stable dosage of risperidone ≥4 mg daily as maintenance therapy.
- Total score ≤70 on the Positive and Negative Syndrome Scale.
- Using a medically accepted contraceptive method
- Agrees to washout all prohibited medications prior to baseline (day -1)
Exclusion Criteria
- Informed consent obtained from a third party.
- Prisoners or patients who are compulsorily detained.
- Females who are breast-feeding and/or who have a positive pregnancy test.
- Presence of an uncontrolled, unstable clinically significant medical condition.
- Positive serology for Hepatitis B, Hepatitis C or anti-HIV 1 and 2 at screening.
- History of neuroleptic malignant syndrome.
- Current or past history of tardive dyskinesia.
- Positive urine drug or alcohol screen finding.
- Risk of committing self-harm or harm based on Columbia Suicidal Rating Scale.
- Taking more than one antidepressant.
- Use of depot antipsychotics within the last three months.
- Use of strong or moderate cytochrome P450 isoenzyme 3A4inducers
- Use of electroconvulsive therapy (ECT) within the last three months.
- Receipt of any investigational drugs within the last three months.
- Known or suspected allergy or hypersensitivity to risperidone
- Previous non-responder to risperidone treatment.
Data sourced from ClinicalTrials.gov (NCT02086786). 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.