Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT07292233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Food Effect Study of LY03020 in Healthy Subjects
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax) of LPM787000048 in plasma', 'timeFrame': 'up to Day 12'}, {'measure': 'Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma', 'timeFrame': 'up to Day 12'}, {'measure': 'Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma', 'timeFrame': 'up to Day 12'}], 'secondaryOutcomes': [{'measure': 'Time to maximum observed concentration (Tmax) of LPM787000048 in plasma', 'timeFrame': 'up to Day 12'}, {'measure': 'Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma', 'timeFrame': 'up to Day 12'}, {'measure': 'Number of participants with adverse events (AEs).', 'timeFrame': 'up to Day 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', "Alzheimer's Disease Psychosis"]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects sign informed consent voluntarily.\n* Male or female aged 18 to 45 years.\n* Body weight ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2.\n\nExclusion Criteria:\n\n* Subjects have any clinically significant medical condition or chronic disease.\n* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.\n* Subjects with a history of orthostatic hypotension or syncope.\n* Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.\n* Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.\n* Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.\n* Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to first dosing.\n* Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation.\n* Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody.'}, 'identificationModule': {'nctId': 'NCT07292233', 'briefTitle': 'A Food Effect Study of LY03020 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luye Pharma Group Ltd.'}, 'officialTitle': 'A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Phase I Clinical Study to Evaluate the Food Effect on the Pharmacokinetics of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'LY03020/CT-CHN-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fasted,fed', 'description': 'Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively.', 'interventionNames': ['Drug: LY03020']}, {'type': 'EXPERIMENTAL', 'label': 'fed,fasted', 'description': 'Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively.', 'interventionNames': ['Drug: LY03020']}], 'interventions': [{'name': 'LY03020', 'type': 'DRUG', 'description': 'single dose，administered orally for each period', 'armGroupLabels': ['fasted,fed', 'fed,fasted']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing AnDing Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luye Pharma Group Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}