Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-30 @ 4:24 PM
Study NCT ID:
NCT06276361
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2024-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'λz', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Terminal elimination rate constant'}, {'measure': 't1/2', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Terminal elimination half-life'}, {'measure': 'Tmax', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Time to peak concentration'}, {'measure': 'Cmax', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Peak plasma concentration'}, {'measure': 'Cmin', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Minimum plasma concentration'}, {'measure': 'Clast', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Last observed plasma concentration'}, {'measure': 'AUC0-t', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Area under the curve'}, {'measure': 'AUCinf', 'timeFrame': 'Following QUAR administration until day 196', 'description': 'Area under the curve'}, {'measure': 'AUCextrap', 'timeFrame': 'Following QUAR administration until day 196', 'description': 'Area under the curve'}, {'measure': 'Vd/F', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Apparent volume of distribution'}, {'measure': 'Cl/F', 'timeFrame': 'Following Oral and QUAR administration until day 17 or 196 respectively', 'description': 'Apparent total body clearance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The study will assess the PK, safety and tolerability of QUAR when administered as a single IM injection, in patients with schizophrenia. The study will be conducted with 3 different dose strengths and up to two formulations.\n\nAfter eligibility confirmation, an oral treatment period follow by a washout period will be performed before QUAR IM administration.\n\nThe different cohorts will be administered with one of the following dosages of Risperidone QUAR:\n\nCohort 1/2: Formulation 1 or 2. Dose level 1 (Gluteal); Cohort 1a/2a: Formulation 1 or 2. Dose level 2 (Gluteal); Cohort 1b/2b: Formulation 1 or 2. Dose level 3 (Gluteal); Cohort 1c/2c: Formulation 1 or 2. Dose level 3 (Deltoid);\n\nThe progression to the next cohorts will take place after a clinical safety assessment. Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.\n\nAfter assessment of Cohort 1 (formulation 1, Dose Level 1, -gluteus-) progression to the next cohort with same formulation and escalating dose will take place (Cohort 1a -gluteus-). After assessment of Cohort 1a, progression and randomization (gluteus/deltoid) to the next cohorts with same formulation and escalating dose will take place (Cohort 1b -gluteus- and Cohort 1c -deltoid-). In this scenario, none of the Cohorts 2 will be conducted.\n\nIf the assessment for Cohort 1 is not adequate, none of the subsequent Cohorts 1 (a/b/c) will be conducted and progression to the next cohort (Cohort 2) with different formulation and same level of dose as Cohort 1 will take place (Cohort 2: Formulation 2, Dose Level 1 -gluteus-). After assessment of Cohort 2, progression to the next cohort with same formulation and escalating dose will take place (Cohort 2a -gluteus-). After assessment of Cohort 2a, progression and randomization (gluteus/deltoid) to the next cohorts with same formulation and escalating dose will take place (Cohort 2b -gluteus- and Cohort 2c -deltoid-).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Capable of providing informed consent.\n* Male or female aged ≥ 18 years to \\< 65 years with BMI ≥17.0 to ≤35.0 kg/m2\n* Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria.\n* Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment\n* currently taking oral risperidone as maintenance therapy\n* Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S)\n* If a sexually active female of childbearing potential, using a medically accepted method of birth control.\n\nExclusion Criteria:\n\n* 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\n* 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.\n* History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia.\n* The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment\n* Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use.\n* In the investigator's opinion, at imminent risk of committing self-harm or harm to others.\n* 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).\n* Receipt study drug in another investigational study in the last 90 days.\n* Current participation in any other clinical trial."}, 'identificationModule': {'nctId': 'NCT06276361', 'acronym': 'QUARTZ', 'briefTitle': 'Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rovi Pharmaceuticals Laboratories'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'ROV-QUAR-2023-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1/2', 'description': 'Patient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 1 dose.', 'interventionNames': ['Drug: Oral risperidone; QUAR F1/2, Dose 1 - Gluteal']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1a/2a', 'description': 'Patient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 2 dose.', 'interventionNames': ['Drug: Oral risperidone; QUAR F1/2, Dose 2 - Gluteal']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1b//2b', 'description': 'Patient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 3 dose.', 'interventionNames': ['Drug: Oral risperidone; QUAR F1/2, Dose 3 - Gluteal']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1c/2c', 'description': 'Patient will recieve oral risperidone for one week followed by a single IM injection of Risperidone QUAR out of two possible formulations (F1/F2) with a level 3 dose.', 'interventionNames': ['Drug: Oral risperidone; QUAR F1/2, Dose 3 - Deltoids']}], 'interventions': [{'name': 'Oral risperidone; QUAR F1/2, Dose 1 - Gluteal', 'type': 'DRUG', 'description': 'Dose level 1', 'armGroupLabels': ['Cohort 1/2']}, {'name': 'Oral risperidone; QUAR F1/2, Dose 2 - Gluteal', 'type': 'DRUG', 'description': 'Dose level 2', 'armGroupLabels': ['Cohort 1a/2a']}, {'name': 'Oral risperidone; QUAR F1/2, Dose 3 - Gluteal', 'type': 'DRUG', 'description': 'Dose level 3', 'armGroupLabels': ['Cohort 1b//2b']}, {'name': 'Oral risperidone; QUAR F1/2, Dose 3 - Deltoids', 'type': 'DRUG', 'description': 'Dose level 3', 'armGroupLabels': ['Cohort 1c/2c']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amman', 'country': 'Jordan', 'facility': 'Investigational Site', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rovi Pharmaceuticals Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}