Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT01684605
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2012-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2012-09-11', 'studyFirstSubmitQcDate': '2012-09-11', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess AUClast of darbepoetin alfa', 'timeFrame': 'Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h'}, {'measure': 'Assess Cmax of darbepoetin alfa', 'timeFrame': 'Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h'}], 'secondaryOutcomes': [{'measure': 'Assess AUCinf of darbepoetin alfa', 'timeFrame': 'Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h'}, {'measure': 'Assess Tmax of darbepoetin alfa', 'timeFrame': 'Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h'}, {'measure': 'Assess t1/2 of darbepoetin alfa', 'timeFrame': 'Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h'}, {'measure': 'Assess CL of darbepoetin alfa', 'timeFrame': 'Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CKD-11101', 'NESP', 'Darbepoetin alfa', 'Anemia', 'intravenous', 'Pharmacokinetics', 'Phase 1'], 'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after IV administration in health male volunteers', 'detailedDescription': 'Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once intravenously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed the informed consent form prior to study participation.\n* A healthy male volunteer between 20 and 55 years old.\n* Body weight between 55kg and 90kg, BMI between 18 and 27.\n* Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)\n\nExclusion Criteria:\n\n* Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases\n* Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor\n* Have abnormal laboratory result.\n\n * Hemoglobin \\< 12g/dL or \\> 17g/dL\n * Vitamin B12 \\< 200pg/mL\n * Ferritin \\< 21.8ng/mL\n * Transferrin \\< 190mg/dL\n * Reticulocyte over the normal limit\n * Positive for the Triage TOX drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)\n * Positive for HIV antibody, HBsAg, HCV antibody test\n* A heavy smoker (cigarette \\> 10 cigarettes per day)\n* Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration\n* Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron tablets\n* sit SBP \\< 90mmHg or sit SBP \\> 140mmHg or sit DBP \\< 55mmHg or sit DBP \\> 90mmHg or Pulse rate \\> 100 per/min\n* History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening\n* Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days before the first IP administration\n* Participated in the other clinical trials and administrated IP within 8 weeks prior to the first IP administration\n* A heavy alcohol consumer (alcohol \\> 21 units/week) or cannot stop drinking\n* Bleed or donate blood (\\> 400mL) within 8 weeks before the first IP administration\n* Participated in this clinical trials and administrated IP\n* Have a diet within 2 days before the first IP administration or cannot stop having\n\n * food containing grapefruit\n * food containing caffeine\n* Disagree to avoid getting pregnant during clinical trial\n* An impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason"}, 'identificationModule': {'nctId': 'NCT01684605', 'briefTitle': 'Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After IV Administration in Health Male Volunteers', 'orgStudyIdInfo': {'id': '136HPS12D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NESP 60μg', 'description': 'Prefilled syringe filled with Darbepoetin alfa 60μg', 'interventionNames': ['Drug: NESP 60μg']}, {'type': 'EXPERIMENTAL', 'label': 'CKD-11101 60μg', 'description': 'Prefilled syringe filled with Darbepoetin alfa 60μg', 'interventionNames': ['Drug: CKD-11101 60μg']}], 'interventions': [{'name': 'NESP 60μg', 'type': 'DRUG', 'description': 'Administrated NESP 60μg once intravenously', 'armGroupLabels': ['NESP 60μg']}, {'name': 'CKD-11101 60μg', 'type': 'DRUG', 'description': 'Administrated CKD-11101 60μg once intravenously', 'armGroupLabels': ['CKD-11101 60μg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul national university hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung Sang Yu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}