Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-01-05 @ 6:14 PM
Study NCT ID:
NCT04630366
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2020-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1, First Time in Humans Study of NST-1024
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-01', 'studyFirstSubmitDate': '2020-11-05', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': '4 weeks', 'description': 'incidence and severity of adverse events'}], 'secondaryOutcomes': [{'measure': 'AUC', 'timeFrame': '3-17 days', 'description': 'Area under the PK curve'}, {'measure': 'Cmax', 'timeFrame': '3-17 days', 'description': 'Maximum plasma concentration'}, {'measure': 'Half life', 'timeFrame': '3-17 days', 'description': 'time to reduction in plasma levels by 50%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'A first time in man study of NST-1024', 'detailedDescription': 'A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects with Elevated Triglycerides. This will be a double-blind, randomised, placebo-controlled, single and multiple oral dose study conducted in 2 parts. In part A up to 6 cohorts of 8 healthy volunteers will receive single ascending doses of NST-1024 or matching placebo. I part B up to 4 cohorts of 10 otherwise healthy volunteers, with elevated triglycerides will receive daily multiple ascending doses of NST-1024 for 14 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18-32 kg/m2\n* In good health\n* Females will not be pregnant or lactating. Females of childbearing potential must agree to use contraception\n* Male subjects must agree to use contraception and refrain from donation of sperm\n* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.\n* Subjects must have TG levels \\> 150 mg/dL at screening (Part B only).\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, CV, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).\n* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).\n* Aspartate aminotransferase, ALT, GGT, ALP, or total bilirubin \\> 1.2 × ULN at Screening or (first) Check-in, confirmed by 1 repeat if necessary\n* History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.\n* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives (whichever is longer) prior to dosing.\n* Use of tobacco- or nicotine-containing products within 1 month prior to Screening, or positive cotinine test at Screening or Check-in.'}, 'identificationModule': {'nctId': 'NCT04630366', 'briefTitle': 'A Phase 1, First Time in Humans Study of NST-1024', 'organization': {'class': 'INDUSTRY', 'fullName': 'NorthSea Therapeutics B.V.'}, 'officialTitle': 'A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects With Elevated Triglycerides', 'orgStudyIdInfo': {'id': 'NST-1024-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NST-1024', 'description': 'NST-1024 capsules given once daily for up to 14 days', 'interventionNames': ['Drug: NST-1024']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo capsules to NST-1024 given once daily for up to 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NST-1024', 'type': 'DRUG', 'description': 'NST-1024', 'armGroupLabels': ['NST-1024']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to NST-1024', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Covance Leeds Clinical Research Unit', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NorthSea Therapeutics B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}