Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 12:00 PM
Study NCT ID:
NCT01334034
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2011-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of NNC 0123-0000-0338 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-04-11', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'from trial product administration and until completion of the dosing visit (Day 0 to Day 6)'}], 'secondaryOutcomes': [{'measure': 'Area under the serum insulin concentration-time curve', 'timeFrame': 'from 0 to 120 hours after a single dose'}, {'measure': 'Area under the glucose infusion rate-time curve', 'timeFrame': 'from 0 to 24 hours after a single dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subject\n* Body mass index (BMI) between 18 and 28 kg/m\\^2 (both inclusive)\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to trial products or related products\n* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician\n* Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician'}, 'identificationModule': {'nctId': 'NCT01334034', 'briefTitle': 'Safety of NNC 0123-0000-0338 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0123-0000-0338 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'NN1953-3832'}, 'secondaryIdInfos': [{'id': 'U1111-1118-2525', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2010-023885-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose levels 1-7', 'interventionNames': ['Drug: NNC 0123-0000-0338', 'Drug: placebo', 'Drug: insulin glargine']}], 'interventions': [{'name': 'NNC 0123-0000-0338', 'type': 'DRUG', 'description': 'Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.', 'armGroupLabels': ['Dose levels 1-7']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels.', 'armGroupLabels': ['Dose levels 1-7']}, {'name': 'insulin glargine', 'type': 'DRUG', 'description': 'As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.', 'armGroupLabels': ['Dose levels 1-7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}