Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-11 @ 4:50 AM
Study NCT ID:
NCT03233932
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CKD-841 Pharmacokinetic/Pharmacodynamic Study
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of Leuprorelin', 'timeFrame': 'From before injection to up to 1008 hours post injection', 'description': 'Peak Plasma Concentration (Cmax) in ng/mL'}, {'measure': 'Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin', 'timeFrame': 'From before injection to up to 1008 hours post injection', 'description': 'Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL'}, {'measure': 'Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin', 'timeFrame': 'From before injection to up to 1008 hours post injection', 'description': 'Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL'}, {'measure': 'Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin', 'timeFrame': 'From before injection to up to 1008 hours post injection', 'description': 'Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL'}, {'measure': 'The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin', 'timeFrame': 'From before injection to up to 1008 hours post injection', 'description': 'The time -to-maximal serum or plasma concentrations (Tmax) in hr'}, {'measure': 'Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin', 'timeFrame': 'From before injection to up to 1008 hours post injection', 'description': 'Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L'}, {'measure': 'Follicular Stimulating Hormone(FSH) of Leuprorelin', 'timeFrame': 'From before injection to up to 1008 hours post injection', 'description': 'Follicular Stimulating Hormone(FSH) in IU/L'}, {'measure': 'Estradiol of Leuprorelin', 'timeFrame': 'From before injection to up to 1008 hours post injection', 'description': 'Estradiol in pg/ml'}], 'secondaryOutcomes': [{'measure': 'Safety Assessment by evaluating adverse events(AEs).', 'timeFrame': 'From day1 to day 56', 'description': 'Assessment of the safety of subjects by evaluating adverse events(AEs).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CKD-841', 'Leuplin', 'Postmenopausal'], 'conditions': ['Postmenopausal Disorder']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female.', 'detailedDescription': 'To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj. 3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy menopausal female\n* β-hCG is negative at screening and before administration of investigational drug\n* Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc...\n* Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and \\< 25\n\nExclusion Criteria:\n\n* History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease\n* Uncontrolled diabetes mellitus\n* Pregnancy or breast feeding\n* History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug\n* Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially\n* Has abnormal function of liver and kidney at screening'}, 'identificationModule': {'nctId': 'NCT03233932', 'briefTitle': 'CKD-841 Pharmacokinetic/Pharmacodynamic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female', 'orgStudyIdInfo': {'id': '155HPS14022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LeuplinⓡInj', 'description': 'LeuplinⓡInj(=leuprorelin acetate 3.75mg)', 'interventionNames': ['Drug: LeuplinⓡInj']}, {'type': 'EXPERIMENTAL', 'label': 'CKD-841', 'description': 'CKD-841(=leuprorelin acetate 3.75mg)', 'interventionNames': ['Drug: CKD-841']}], 'interventions': [{'name': 'LeuplinⓡInj', 'type': 'DRUG', 'description': 'Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.', 'armGroupLabels': ['LeuplinⓡInj']}, {'name': 'CKD-841', 'type': 'DRUG', 'description': 'Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.', 'armGroupLabels': ['CKD-841']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'state': 'Yonsei-ro, Seodaemun-gu 50-1', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Min Soo Park, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Severance Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}