Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT05316259
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Food-Effect Study of BPI-16350 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-07', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Maximum observed concentration'}, {'measure': 'AUC0-t', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Area under the concentration-time curve from time 0 to time t'}, {'measure': 'AUC0-∞', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Area under the concentration-time curve from time 0 to infinity'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Time to reach maximum observed plasma concentration'}, {'measure': 't1/2', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Half-life time'}, {'measure': 'λz', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Elimination rate constant'}, {'measure': 'tlag', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Lag Time'}, {'measure': 'AUC %Extrap', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Percentage of AUCinf due to extrapolation from Tlast to infinity'}, {'measure': 'CL/F', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Apparent Oral Clearance'}, {'measure': 'V/F', 'timeFrame': 'from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose', 'description': 'Apparent Volume of Distribution'}, {'measure': 'Characterize the safety of BPI-16350', 'timeFrame': 'from Day 1 to Day 23', 'description': 'Number of subjects with treatment related adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.\n\nSubjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects aged 18\\~45 (including 18 and 45 years old);\n* Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 \\~ 26kg /m2;\n* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;\n* The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；\n* Able to comprehend and willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* History of significant hypersensitivity to any drug compound or food；\n* Significant history or clinical manifestation of any significant cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, musculoskeletal,hematological disorder；\n* Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody is positive；\n* Family history of long QTc syndrome; History or presence of an abnormal ECG；\n* Drug abusers, smokers or alcoholics；\n* Use of any medications within 14 days prior to the first administration；\n* Donation of blood ≥ 200 mL or receipt of blood products within 3 months before enrollment, or plan on blood donation during the study period；\n* Participation in any other investigational drug study or receive any vaccine within 3 months before enrollment；\n* Female subjects who are pregnant or lactating；the serum HCG test of women with fertility is postive at Screening.'}, 'identificationModule': {'nctId': 'NCT05316259', 'briefTitle': 'A Food-Effect Study of BPI-16350 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Betta Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase 1, Single-center, Open-Label, Randomized, 2 Period Crossover Study to Estimate the Effect of Food on the Pharmacokinetics of BPI-16350 in Chinese Healthy Volunteers After a Single Oral Administration', 'orgStudyIdInfo': {'id': 'BTP-66732FE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A（Dosing in the fasted state followed by fed dosing）', 'description': 'Dosing in the fasted state followed by fed dosing.A washout period of 14 days will be maintained between the 2 treatment periods.', 'interventionNames': ['Drug: BPI-16350']}, {'type': 'EXPERIMENTAL', 'label': 'Group B（Dosing in the fed state followed by fasted dosing）', 'description': 'Dosing in the fed state followed by fasted dosing.A washout period of 14 days will be maintained between the 2 treatment periods.', 'interventionNames': ['Drug: BPI-16350']}], 'interventions': [{'name': 'BPI-16350', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Group A（Dosing in the fasted state followed by fed dosing）', 'Group B（Dosing in the fed state followed by fasted dosing）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Haibin Yu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}