NCT06276361CompletedPhase 1
Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With 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)
Source: ClinicalTrials.gov · Last updated 8 Sept 2025
Brief summary (registry, in English)
This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 16 Feb 2024
- Start date
- 26 Sept 2023
- Primary completion date
- 7 Jul 2025
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Diseases
- Schizophrenia
- NCT number
- NCT06276361
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 58
- From 26 Sept 2023 to the primary completion date, 7 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use.
- 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.
Other illness
- 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
- 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
Lab values
- 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.
Other
- In the investigator's opinion, at imminent risk of committing self-harm or harm to others.
- Current participation in any other clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.