Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-01 @ 5:00 PM
Study NCT ID:
NCT05857566
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-19', 'releaseDate': '2025-12-05'}], 'estimatedResultsFirstSubmitDate': '2025-12-05'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1b, randomized, open-label, parallel group study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglyceride and apolipoprotein B48 (ApoB48)', 'timeFrame': '7 days', 'description': 'Efficacy of treatment with RDX-002 on postprandial triglyceride levels and apolipoprotein B48 (ApoB48) levels in normal healthy volunteers treated with 10 mg olanzapine.'}], 'secondaryOutcomes': [{'measure': 'Triglyceride Level', 'timeFrame': '7 days', 'description': 'Evaluate the effect of treatment with 10 mg olanzapine on postprandial triglyceride levels and ApoB48 levels in normal healthy volunteers'}, {'measure': 'Cmax', 'timeFrame': '7 days', 'description': 'Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine'}, {'measure': 'Fasting Lipids', 'timeFrame': '7 days', 'description': 'Assess the effects of olanzapine and olanzapine with RDX-002 on fasting lipids'}, {'measure': 'AUC', 'timeFrame': '7 days', 'description': 'Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine'}, {'measure': 't1/2', 'timeFrame': '7 days', 'description': 'Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug-induced Weight Gain']}, 'descriptionModule': {'briefSummary': 'This Phase 1b Study RDX-002-22-09 has been planned to evaluate the effect of RDX-002 on postprandial triglycerides and ApoB48 levels in normal healthy subjects treated with the atypical antipsychotic drug, olanzapine.', 'detailedDescription': 'This Phase 1b Study RDX-002-22-09 has been planned to evaluate the effect of RDX-002 on postprandial triglycerides and ApoB48 levels in normal healthy subjects treated with the atypical antipsychotic drug, olanzapine. It is a randomized, open-label, parallel group study that will be conducted at a single study site in the US. Normal, healthy subjects aged 18-50 years and with a body mass index (BMI) of 18-27.5 kg/m2 will be eligible for screening. Screening (Day -28) will begin approximately 28 days prior to Baseline (Day 1). Subjects will be admitted to the clinical research unit (CRU) on the morning of Day -1 and will remain in the CRU until discharge on Day 16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A glycated hemoglobin (HbA1c) level of \\<5.7% at Screening\n* A 12-lead electrocardiogram (ECG) at Screening which, in the opinion of the Investigator, had no abnormalities that compromised safety in this study\n* Hematology, clinical chemistry and urinalysis at Screening, the results of which fall within normal parameter ranges and/or are deemed clinically acceptable by the Investigator Exclusion Criteria\n* Males and nonpregnant, nonlactating females\n\nExclusion Criteria:\n\n* Any prior use of or contraindication to atypical antipsychotics\n* Concomitant use of drugs known to impact the PK of olanzapine\n* Type 1 or Type 2 diabetes\n* Recent CV event\n* Uncontrolled hypertension\n* Fasting triglycerides ≥400 mg/dL\n* Fasting glucose ≥100 mg/dL\n* Any condition that impacts the absorption of dietary fats\n* Significant gastrointestinal disorders\n* Gall bladder disease\n* Uncontrolled hypothyroidism\n* Liver disease or dysfunction\n* Renal disease or dysfunction\n* Gastrointestinal conditions\n* Hematologic disorders\n* Active malignancy\n* Psychiatric disorder\n* History of drug or alcohol abuse\n* Pregnant, breastfeeding, or intending to become pregnant\n* Use of weight loss products\n* Blood donation or loss within 30 days prior to Screening'}, 'identificationModule': {'nctId': 'NCT05857566', 'briefTitle': 'Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Response Pharmaceuticals'}, 'officialTitle': 'A Randomized, Open-Label Study of the Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With the Atypical Antipsychotic Drug, Olanzapine', 'orgStudyIdInfo': {'id': 'RDX-002-22-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RDX-002', 'description': '50 mg oral tablet; 200 mg BID for 7 days', 'interventionNames': ['Drug: RDX-002']}, {'type': 'OTHER', 'label': 'Olanzapine', 'description': '10 mg oral tablet; 10 mg QD for 14 days', 'interventionNames': ['Drug: RDX-002']}], 'interventions': [{'name': 'RDX-002', 'type': 'DRUG', 'description': 'A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.', 'armGroupLabels': ['Olanzapine', 'RDX-002']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Nucleus Network', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Tricia Stamp, PhD, PA-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nucleus Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing of IPD with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Response Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-05', 'type': 'RELEASE'}, {'date': '2025-12-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Response Pharmaceuticals'}}}}