Evaluating a new injectable formulation of Risperidone for schizophrenia
A Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Intramuscular Injection of Quarterly Risperidone (QUAR) for Different Formulations and Dose Strengths in Participants With Schizophrenia (QUARTZ Study)
PHASE1 · Rovi Pharmaceuticals Laboratories · NCT06276361
This study is testing a new injectable form of Risperidone to see if it is safe and effective for people with schizophrenia.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Rovi Pharmaceuticals Laboratories (industry) |
| Locations | 1 site (Amman) |
| Trial ID | NCT06276361 on ClinicalTrials.gov |
What this trial studies
This phase 1 study aims to assess the pharmacokinetics, safety, and tolerability of a single intramuscular injection of quarterly Risperidone (QUAR) in patients diagnosed with schizophrenia. Participants will receive different formulations and dose strengths of the medication, with careful monitoring of their health and response to treatment. The study will involve an oral treatment period followed by a washout before administering the QUAR injection, and will progress through multiple cohorts based on safety assessments. Blood samples will be collected to evaluate the drug's pharmacokinetics at various time points.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a diagnosis of schizophrenia who are currently stable on oral risperidone.
Not a fit: Patients with uncontrolled medical conditions or those who are pregnant or planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with schizophrenia through a more effective and convenient medication formulation.
How similar studies have performed: While this approach is novel in its specific formulation and dosing strategy, similar studies have shown promise in improving treatment adherence and outcomes for schizophrenia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Capable of providing informed consent. * Male or female aged ≥ 18 years to \< 65 years with BMI ≥17.0 to ≤35.0 kg/m2 * Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria. * Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment * currently taking oral risperidone as maintenance therapy * Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S) * If a sexually active female of childbearing potential, using a medically accepted method of birth control. Exclusion Criteria: * Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations * If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child. * History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia. * The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment * Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use. * In the investigator's opinion, at imminent risk of committing self-harm or harm to others. * Unwilling to discontinue any of the prohibited medications prior to the baseline visit or unable to safely washout such medication without significant destabilization or increased risk of self-harm (suicide). * Receipt study drug in another investigational study in the last 90 days. * Current participation in any other clinical trial.
Where this trial is running
Amman
- Investigational Site — Amman, Jordan (RECRUITING)
Study contacts
- Study coordinator: Clinical Operations Laboratorios farmacéuticos ROVI
- Email: departamento.medico@rovi.es
- Phone: +34913756230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia