Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-29 @ 2:45 AM
Study NCT ID:
NCT01405261
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2011-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overview of Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'Up to 25 days after trial product administration'}], 'secondaryOutcomes': [{'measure': 'Frequency of hypoglycaemic episodes', 'timeFrame': 'From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration)'}, {'measure': 'AUC0-240h; area under the NNC 0113-0987 concentration-time curve', 'timeFrame': 'From time 0 to 240 hours after a single oral or intravenous (i.v.) dose'}, {'measure': 'AUC, area under the curve', 'timeFrame': 'From time 0 to infinity after a single oral or i.v. dose'}, {'measure': 'Cmax; maximum concentration of NNC 0113-0987 in plasma', 'timeFrame': 'After a single oral or i.v. dose'}, {'measure': 'The time to maximum concentration (tmax) of NNC 0113-0987 in plasma', 'timeFrame': 'After a single oral dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2', '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 safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments at the screening visit\n* Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m\\^2\n\nExclusion Criteria:\n\n* Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication\n* The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial\n* Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the investigator\n* Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies\n* History of chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)'}, 'identificationModule': {'nctId': 'NCT01405261', 'briefTitle': 'Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'NN9926-3894'}, 'secondaryIdInfos': [{'id': 'U1111-1119-1560', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2011-000297-57', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC 0113-0987 (gastro)', 'interventionNames': ['Drug: oral NNC 0113-0987', 'Drug: oral placebo']}, {'type': 'EXPERIMENTAL', 'label': 'NNC 0113-987 (coated)', 'interventionNames': ['Drug: oral NNC 0113-0987', 'Drug: oral placebo']}, {'type': 'EXPERIMENTAL', 'label': 'NNC 0113-987 (i.v)', 'interventionNames': ['Drug: I.v. NNC 0113-0987']}], 'interventions': [{'name': 'oral NNC 0113-0987', 'type': 'DRUG', 'description': 'Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.', 'armGroupLabels': ['NNC 0113-0987 (gastro)']}, {'name': 'oral NNC 0113-0987', 'type': 'DRUG', 'description': 'Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.', 'armGroupLabels': ['NNC 0113-987 (coated)']}, {'name': 'I.v. NNC 0113-0987', 'type': 'DRUG', 'description': 'Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.', 'armGroupLabels': ['NNC 0113-987 (i.v)']}, {'name': 'oral placebo', 'type': 'DRUG', 'description': 'Subjects will be randomised to receive a single dose of placebo.', 'armGroupLabels': ['NNC 0113-0987 (gastro)', 'NNC 0113-987 (coated)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], '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'}}}}