Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-27 @ 1:08 AM
Study NCT ID:
NCT06057103
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053139', 'term': 'Oseltamivir'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules', 'timeFrame': 'Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20', 'description': 'Cmax'}, {'measure': 'PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules', 'timeFrame': 'Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20', 'description': 'AUC0-t'}, {'measure': 'PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules', 'timeFrame': 'Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20', 'description': 'AUC0-inf'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Interaction']}, 'descriptionModule': {'briefSummary': 'The primary object of this study is evaluating the effect of multiple oral oseltamivir phosphate capsules on the pharmacokinetic profile of the active metabolite ZX-7101 after a single oral administration of ZX-7101A tablet in healthy Chinese adult subjects.\n\nThe seongdary object is evaluating combined or uncombined multiple oral oseltamivir phosphate in healthy Chinese adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHealthy male or female subjects between the ages of 18 and 45 years (including the threshold value, based on the date of signing ICF).\n\nWeight: Male weight ≥50 kg, female weight ≥45 kg, BMI between 19.0 and 28.0 kg/m2 (including cut-off value), BMI= weight (kg)/height 2 (m2).\n\nThe investigator judged the subjects to be in good overall health based on their medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (routine blood work, urine work, blood biochemistry, coagulation function), viral serology, and chest X-ray results (normal or abnormal test results have no clinical significance).\n\nFertile female subjects or male subjects who voluntarily signed ICF should be no fertile, sperm/egg donation for 6 months (female) or 90 days (male) from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).\n\nFully understand the trial content and possible adverse reactions, have the ability to communicate with researchers normally, while complying with study requirements, follow protocol procedures and restrictions, and be able to visit on time.\n\nExclusion Criteria:\n\nSubjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.\n\nSubjects with digestive tract disease or any condition that may affect drug absorption, such as a history of liver and gallbladder disease, gastrointestinal disease, gastrointestinal surgery (except appendectomy) or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.\n\nAllergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.\n\nAcute respiratory infections within 2 weeks before screening; Or have a history of fungal infection.\n\nFor patients with abnormal vital signs (blood pressure, pulse rate, ear temperature) and clinically significant results, the abnormal values of each vital sign are:Body temperature (ear temperature) \\>37.5 ℃; Systolic blood pressure (recumbent) \\<90 mmHg or ≥140 mmHg; Diastolic blood pressure (lying) \\<50 mmHg or ≥90 mmHg; Pulse rate (lying position) \\<50 beats/min or \\>100 beats/min.\n\nQTcF interval \\> 450ms or \\< 300 ms (Fridericia's correction), or QRS\\>120ms. Abnormal liver function: alanyl aminotransferase (ALT) or aspartate aminotransferase (AST) higher than the upper limit of normal or serum total bilirubin (TBIL) greater than 1.5 times the upper limit of normal, who judged clinical significance by investigators.\n\nSubjects estimate glomerular filtration rate \\<90 mL/min/1.73 m2. Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results.\n\nSubjects with a history of drug abuse (morphine, dimethylene dioxyamphetamine, methamphetamine, THC, ketamine, cocaine) or who screened positive for drug abuse.\n\nWomen who are pregnant or breastfeeding, or who test positive for blood pregnancy.\n\nSubjects who have used any P-gp or CYP inducer or inhibitor within 30 days before screening, or any prescription or Chinese herbal medicine within 4 weeks before the start of the trial, or over-the-counter or health care products (including polyvalent cations and metal supplements, etc.) within 2 weeks before the start of the trial; It should have a longer time interval if the elimination half-life is longer-at least 5 elimination half-lives for the drug."}, 'identificationModule': {'nctId': 'NCT06057103', 'acronym': 'ZX-7101A-208', 'briefTitle': 'A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Zenshine Pharmaceuticals'}, 'officialTitle': 'A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects -a Single-center, Open-labelled, Six-sequence, Three-cycle Crossover Design', 'orgStudyIdInfo': {'id': 'ZX-7101A-208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ZX-7101A-1', 'interventionNames': ['Drug: ZX-7101A', 'Drug: Oseltamivir', 'Drug: ZX-7101A and Oseltamivir']}, {'type': 'OTHER', 'label': 'ZX-7101A-2', 'interventionNames': ['Drug: ZX-7101A', 'Drug: ZX-7101A and Oseltamivir', 'Drug: Oseltamivir']}, {'type': 'OTHER', 'label': 'Oseltamivir-1', 'interventionNames': ['Drug: Oseltamivir', 'Drug: ZX-7101A', 'Drug: ZX-7101A and Oseltamivir']}, {'type': 'OTHER', 'label': 'Oseltamivir-2', 'interventionNames': ['Drug: Oseltamivir', 'Drug: ZX-7101A and Oseltamivir', 'Drug: ZX-7101A']}, {'type': 'OTHER', 'label': 'Combined-1', 'interventionNames': ['Drug: ZX-7101A and Oseltamivir', 'Drug: ZX-7101A', 'Drug: Oseltamivir']}, {'type': 'OTHER', 'label': 'Combined-2', 'interventionNames': ['Drug: ZX-7101A and Oseltamivir', 'Drug: Oseltamivir', 'Drug: ZX-7101A']}], 'interventions': [{'name': 'ZX-7101A', 'type': 'DRUG', 'description': 'ZX-7101A Tablets single dose tablet, 80 mg, Oral', 'armGroupLabels': ['ZX-7101A-1', 'ZX-7101A-2']}, {'name': 'Oseltamivir', 'type': 'DRUG', 'description': 'Oseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral', 'armGroupLabels': ['Oseltamivir-1', 'Oseltamivir-2', 'ZX-7101A-1']}, {'name': 'ZX-7101A and Oseltamivir', 'type': 'DRUG', 'description': 'ZX-7101A tablet (80mg, single dose) was combined with oseltamivir phosphate capsule (75 mg twice daily),Oral', 'armGroupLabels': ['Combined-1', 'Combined-2', 'Oseltamivir-2', 'ZX-7101A-1', 'ZX-7101A-2']}, {'name': 'ZX-7101A', 'type': 'DRUG', 'description': 'ZX-7101A Tablets single dose tablet, 80 mg, Oral', 'armGroupLabels': ['Combined-1', 'Oseltamivir-1', 'Oseltamivir-2']}, {'name': 'Oseltamivir', 'type': 'DRUG', 'description': 'Oseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral', 'armGroupLabels': ['Combined-1', 'Combined-2', 'ZX-7101A-2']}, {'name': 'ZX-7101A and Oseltamivir', 'type': 'DRUG', 'description': 'ZX-7101A tablet (80mg, single dose) was combined with oseltamivir phosphate capsule (75 mg twice daily),Oral', 'armGroupLabels': ['Oseltamivir-1']}, {'name': 'ZX-7101A', 'type': 'DRUG', 'description': 'ZX-7101A Tablets single dose tablet, 80 mg, Oral', 'armGroupLabels': ['Combined-2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Zenshine Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}