Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-05 @ 5:04 AM
Study NCT ID:
NCT03918967
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2019-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-07', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse events including serious Adverse events (Part I, Part II)', 'timeFrame': '46 days'}, {'measure': 'Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)', 'timeFrame': 'Up to 48 hours after administration'}], 'secondaryOutcomes': [{'measure': 'Safety parameters as assessed by: QT interval of ECG', 'timeFrame': '17 Days'}, {'measure': 'Safety parameters as assessed by: QTcF of ECG', 'timeFrame': '17 Days'}, {'measure': 'Safety parameters as assessed by: blood pressure of Vital signs', 'timeFrame': '17 Days'}, {'measure': 'Safety parameters as assessed by: pulse rate of Vital signs', 'timeFrame': '17 Days'}, {'measure': 'Safety parameters as assessed by: body temperature of Vital signs', 'timeFrame': '17 Days'}, {'measure': 'Safety parameters as assessed by: hematology of Clinical laboratory tests', 'timeFrame': '17 Days'}, {'measure': 'Safety parameters as assessed by: clinical chemistry', 'timeFrame': '17 Days'}, {'measure': 'PK parameters as assessed by : Area under the concentration-time curve (AUC)', 'timeFrame': '13 Days'}, {'measure': 'PK parameters as assessed by : Maximum observed concentration (Cmax)', 'timeFrame': '13 Days'}, {'measure': 'PK parameters as assessed by : Time to Cmax (tmax)', 'timeFrame': '13 Days'}, {'measure': 'PK parameters as assessed by : Terminal half-life time (t1/2)', 'timeFrame': '13 Days'}, {'measure': 'PD parameters as assessed by : Left ventricular ejection fraction (LVEF)', 'timeFrame': '17 Days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:\n\n* Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.\n* Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.\n* Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index (BMI) ≥18.0 and ≤30.0 kg/m2\n\nExclusion Criteria:\n\n* Clinically significant allergic reactions\n* Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator\n* Hepatic dysfunction upper limit of normal laboratory range\n* Cardiac history or presence\n* History or any concomitant active malignancy\n* A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Inherited bleeding diathesis or coagulopathy with the risk of bleeding\n* Hemoptysis, thrombotic or hemorrhagic event\n* Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage\n* History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess\n* Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption'}, 'identificationModule': {'nctId': 'NCT03918967', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)', 'orgStudyIdInfo': {'id': 'CT-G20 1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-G11', 'description': 'CT-G11 Experimental Drug', 'interventionNames': ['Drug: CT-G11']}, {'type': 'EXPERIMENTAL', 'label': 'CT-G20', 'description': 'CT-G20 Experimental Drug', 'interventionNames': ['Drug: CT-G20']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CT-G11 Placebo', 'interventionNames': ['Drug: CT-G11 Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CT-G20 Placebo', 'interventionNames': ['Drug: CT-G20 Placebo']}], 'interventions': [{'name': 'CT-G11', 'type': 'DRUG', 'description': 'oral tablet of CT-G11 Experimental Drug', 'armGroupLabels': ['CT-G11']}, {'name': 'CT-G20', 'type': 'DRUG', 'description': 'oral tablet of CT-G20 Experimental Drug', 'armGroupLabels': ['CT-G20']}, {'name': 'CT-G11 Placebo', 'type': 'DRUG', 'description': 'oral tablet of Placebo', 'armGroupLabels': ['CT-G11 Placebo']}, {'name': 'CT-G20 Placebo', 'type': 'DRUG', 'description': 'oral tablet of Placebo', 'armGroupLabels': ['CT-G20 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Jin Jang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}