Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-01 @ 9:06 AM
Study NCT ID:
NCT04673695
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004341', 'term': 'Drug Evaluation'}], 'ancestors': [{'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2020-11-08', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt(Area Under Curve last) of CKD-344', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose', 'description': 'Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.'}, {'measure': 'Cmax', 'timeFrame': 'predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose', 'description': 'The maximum concentration observed of CKD-344 over blood sampling time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anticoagulant']}, 'descriptionModule': {'briefSummary': 'A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344', 'detailedDescription': 'A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-344.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult volunteers aged ≥ 19 years\n2. Weight ≥60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2\n3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.\n4. Those who are eligible for clinical trials based on laboratory (hematology, blood coagulation, blood chemistry, serology, urinalysis) at screening.\n5. Those who agree to contraception during the participation of clinical trial.\n6. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.\n\nExclusion Criteria:\n\n1. Those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeleto-muscular, immune, etc.\n2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.\n3. Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.\n4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.\n5. Those who donated whole blood within 2 months or blood components within 1 month prior to the first dose of the investigational product.\n6. Those who exceed an alcohol and cigarette consumption than below criteria. A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week B. Smoking: 20 cigarettes/day\n7. Those who exceeds 2 times the upper limit of the reference range of AST(or ALT) or 1.5 times the upper limit of the reference range of γ-GTP.\n8. Those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions.\n9. Those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.)\n10. Those who were deemed inappropriate to participate in the study by the investigator.\n11. Those who have a pregnant or nursing woman.'}, 'identificationModule': {'nctId': 'NCT04673695', 'briefTitle': 'A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'A109_01BE2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': '1. Period 1: Reference drug(Lixiana 60 mg)\n2. Period 2: Test drug(CKD-344 60 mg)', 'interventionNames': ['Drug: Lixiana(D006)', 'Drug: CKD-344']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': '1. Period 1: Test drug(CKD-344 60 mg)\n2. Period 2: Reference drug(Lixiana 60 mg)', 'interventionNames': ['Drug: Lixiana(D006)', 'Drug: CKD-344']}], 'interventions': [{'name': 'Lixiana(D006)', 'type': 'DRUG', 'otherNames': ['Reference Drug'], 'description': 'NOAC(Factor Xa inhibitor)', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'CKD-344', 'type': 'DRUG', 'otherNames': ['Test Drug'], 'description': 'NOAC(Factor Xa inhibitor)', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yook-Hwan Noh', 'role': 'CONTACT', 'email': 'yook.noh@gmail.com', 'phone': '+827046659174'}], 'facility': 'Yook-Hwan Noh', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yook-Hwan Noh, M.D., PhD.', 'role': 'CONTACT', 'email': 'yook.noh@gmail.com', 'phone': '82-70-4665-9174'}, {'name': 'Yook-Hwan Noh, M.D., PhD.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Yook-Hwan Noh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'H Plus Yangji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}