Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-29 @ 10:00 PM
Study NCT ID:
NCT05070195
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2021-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C576190', 'term': 'SKLB1028'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-26', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Maximum concentration (Cmax)of Midazolam and its metabolite 1'-OH-midazolam", 'timeFrame': 'Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)'}, {'measure': "Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of Midazolam and its metabolite 1'-OH-midazolam", 'timeFrame': 'Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)'}, {'measure': "AUC extrapolated to infinity (AUCinf) of Midazolam and its metabolite 1'-OH-midazolam", 'timeFrame': 'Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)'}], 'secondaryOutcomes': [{'measure': "Time to Cmax (Tmax) of Midazolam and its metabolite 1'-OH-midazolam", 'timeFrame': 'Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)'}, {'measure': "Terminal elimination half-life (t1/2) of Midazolam and its metabolite 1'-OH-midazolam", 'timeFrame': 'Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)'}, {'measure': 'Apparent Clearance (CLz/F) of Midazolam', 'timeFrame': 'Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)'}, {'measure': 'Apparent volume of distribution (Vz/F) of Midazolam', 'timeFrame': 'Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Throughout the study period, with an average of 10 days'}, {'measure': 'Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Routine blood test included cell count (white blood cells, platelets, basophils, eosinophils, neutrophils, lymphocytes and monocytes) in 10\\^9/L.'}, {'measure': 'Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Routine blood test included red blood cell count in 10\\^12/L.'}, {'measure': 'Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Routine blood test included hemoglobin in g/L.'}, {'measure': 'Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Blood biochemistry test included total bilirubin and serum creatinine in μmol/L.'}, {'measure': 'Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Blood biochemistry test included alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and creatine kinase in U/L.'}, {'measure': 'Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Blood biochemistry test included total protein and albumin in g/L.'}, {'measure': 'Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Blood biochemistry test included total cholesterol, triglyceride and blood glucose in mmol/L.'}, {'measure': 'Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Routine urine test included urobilinogen, protein, glucose and ketones (positive or negative).'}, {'measure': 'Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Routine urine test included pH value and specific gravity.'}, {'measure': 'Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Coagulation function test included prothrombin time and activated partial thromboplastin time in seconds.'}, {'measure': 'Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Coagulation function test included antithrombin III as percentage.'}, {'measure': 'Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Coagulation function test included fibrinogen in g/L.'}, {'measure': 'Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'ECG monitoring included heart rate in bpm.'}, {'measure': 'Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'ECG monitoring included P-R, QRS, QT and QTcF in ms.'}, {'measure': 'Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Vital signs monitoring included body temperature in degrees Celsius.'}, {'measure': 'Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Vital signs monitoring included respiratory rate and pulse in times per minute.'}, {'measure': 'Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Vital signs monitoring included systolic blood pressure and diastolic blood pressure in mmHg.'}, {'measure': 'Clinically significant changes from baseline in physical examination were recorded as AEs at each visit time point.', 'timeFrame': 'Throughout the study period, with an average of 10 days', 'description': 'Physical examination included general conditions, skin, mucous membranes, head, neck, chest, abdomen, spine, limbs, nervous system, and lymphatic system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': "This is a single-center, open-label phase I clinical study to investigate the effect of SKLB1028 on the pharmacokinetics of Midazolam and its metabolite 1'-OH-midazolam in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Midazolam.", 'detailedDescription': 'This study aims to characterize the drug-drug Interactions (DDI) potential of SKLB1028 with the sensitive index substrate drug (Midazolam) in Healthy Subjects. The study consists of a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nHealthy subjects:\n\n1. Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;\n2. 18 ≤ age ≤45, male;\n3. Subjects with weight ≥50.0 kg and body mass index (BMI) 19-26 kg/m\\^2 (inclusive);\n4. Subjects are willing to use effective non-hormonal contraceptives such as sexual abstinence, and not allowed to donate sperm from screening to the 6 months after the last dose administration unless permanent contraception has been taken, such as vasectomy;\n5. Ability to communicate well with researchers, and be willing to comply with all trial requirements.\n\nExclusion Criteria:\n\n1. Allergic constitution, including a history of allergy to any of the study drugs or other similarly structured drugs;\n2. Previous or current severe diseases, such as cardiovascular, respiratory, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases, or any other disease that can interfere with the results of the study;\n3. Subjects with sleep apnea syndrome;\n4. Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;\n5. Subjects with acute angle closure glaucoma;\n6. Subjects who have previously undergone surgery that may affect the absorption, distribution, metabolism, or excretion of the drug (e.g., subtotal gastrectomy), or who have a scheduled surgical plan during the study period;\n7. Use of any inhibitors or inducers of CYP3A4, or any strong inhibitors or inducers of CYP2C8 or P-gp within 2 weeks prior to screening;\n8. Use of any prescription drug, over-the-counter drug, herbal medicine or health products within 2 weeks prior to screening;\n9. History of drug abuse within 1 year prior to screening, or positive urine drug screen at screening;\n10. Smoking more than 5 cigarettes per day within 6 months prior to screening;\n11. Average daily intake of alcohol more than 14 units (14 units ≈285 mL of beer, or 25 mL of liquor, or 150 mL of wine) within 4 weeks prior to screening, or a positive ethanol breath test at screening;\n12. Consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 48 h before the administration, or those who have had strenuous exercise, or have other factors affecting absorption, distribution, metabolism, excretion, etc of the drug;\n13. Subjects who have received vaccinations within 4 weeks prior to screening;\n14. Participation in another clinical trial within 3 months before screening (whichever is administrated);\n15. Blood donation (or blood loss) ≥200 mL within 4 weeks prior to the screening, or who have a blood donation plan during the entire study or within 1 months after the study;\n16. Any abnormalities of clinical significance in physical examination, vital signs, clinical laboratory tests (routine blood test, blood biochemistry, routine urine test, coagulation function), anteroposterior chest radiograph or chest CT scan;\n17. Abnormalities of clinical significance in 12-lead ECG examination (such as tachycardia/bradycardia in need of medical treatment, II-III degree atrioventricular block, QTcF\\>450 ms or any other clinically significant abnormalities);\n18. Any positive test result of hepatitis B surface antigen or hepatitis C virus antibody, or subjects with a history of hepatitis B;\n19. Any positive test result of anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;\n20. Subjects with a history of fainting needle or blood, cannot tolerate vein puncture for blood collection;\n21. Any condition that, in the opinion of the Investigator, may prevent the subject from completing the study or pose a significant risk to the subject.'}, 'identificationModule': {'nctId': 'NCT05070195', 'briefTitle': 'A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'A Single-center, Open-label, Phase I Drug-drug Interaction Clinical Study to Investigate the Effect of SKLB1028 on the Pharmacokinetics of Midazolam in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HA114-CSP-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The DDI of SKLB1028 and Midazolam', 'description': 'Eligible subjects received a single dose of Midazolam 15 mg on Day 1, and took a single dose of Midazolam 15 mg and a single dose of SKLB1028 150 mg with dosing interval of 0.5 h on Day 3.', 'interventionNames': ['Drug: SKLB1028', 'Drug: Midazolam']}], 'interventions': [{'name': 'SKLB1028', 'type': 'DRUG', 'description': 'SKLB1028, capsule, oral', 'armGroupLabels': ['The DDI of SKLB1028 and Midazolam']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Midazolam Maleate, tablet, oral', 'armGroupLabels': ['The DDI of SKLB1028 and Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}