Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-04-07 @ 6:55 AM
Study NCT ID:
NCT03186495
Status:
COMPLETED
Last Update Posted:
2020-04-17
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718308', 'term': 'somapacitan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-16', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-12', 'lastUpdatePostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the somapacitan serum concentration time curve', 'timeFrame': 'From time 0 to 168 hours after the last dosing on Day 15.', 'description': 'Calculated based on the serum concentrations measured in ug/l'}], 'secondaryOutcomes': [{'measure': 'Maximum serum concentration of somapacitan', 'timeFrame': 'After the last dosing on Day 15 up until Day 43', 'description': 'Measured in ng/ml'}, {'measure': 'Time to maximum serum concentration of somapacitan', 'timeFrame': 'After the last dosing on Day 15 up until Day 43', 'description': 'Calculated based on the serum concentrations measured in ug/l'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Day 0 - 43', 'description': 'Count and % of events'}, {'measure': 'Occurrence of anti-somapacitan antibodies', 'timeFrame': 'Day 0 - 43', 'description': 'Count or % of events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Hormone Disorder', 'Adult Growth Hormone Deficiency', 'Growth Hormone Deficiency in Children']}, 'referencesModule': {'references': [{'pmid': '33754315', 'type': 'DERIVED', 'citation': 'Bentz Damholt B, Dombernowsky SL, Dahl Bendtsen M, Bisgaard C, Hojby Rasmussen M. Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials. Clin Pharmacokinet. 2021 Aug;60(8):1015-1027. doi: 10.1007/s40262-021-00990-7. Epub 2021 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent\n* Body mass index between 18.5-34.9 kg/sqm (both inclusive)\n* Meeting the pre-defined glomerular filtration rate for any of the renal function groups 1-4 (based on the measured glomerular filtration rate using exogenous sinistrin (Inutest®) as a filtration marker) or being in treatment with haemodialysis\n\nExclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration\n* Any disorder, except for conditions associated with renal impairment in the groups of subjects with reduced renal function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. For example, arterial hypertension, anaemia, impaired glucose tolerance or type 2 diabetes are accepted in the group of subjects with renal impairment"}, 'identificationModule': {'nctId': 'NCT03186495', 'briefTitle': 'Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function', 'orgStudyIdInfo': {'id': 'NN8640-4297'}, 'secondaryIdInfos': [{'id': 'U1111-1187-9141', 'type': 'OTHER', 'domain': 'World Health organization (WHO)'}, {'id': '2016-003910-29', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal renal function', 'description': 'Subjects with normal renal function', 'interventionNames': ['Drug: Somapacitan']}, {'type': 'EXPERIMENTAL', 'label': 'Mild renal impairment', 'description': 'Subjects with mild renal impairment', 'interventionNames': ['Drug: Somapacitan']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate renal impairment', 'description': 'Subjects with moderate renal impairment', 'interventionNames': ['Drug: Somapacitan']}, {'type': 'EXPERIMENTAL', 'label': 'Severe renal impairment', 'description': 'Subjects with severe renal impairment', 'interventionNames': ['Drug: Somapacitan']}, {'type': 'EXPERIMENTAL', 'label': 'Requiring haemodialysis treatment', 'description': 'Subjects requiring haemodialysis treatment', 'interventionNames': ['Drug: Somapacitan']}], 'interventions': [{'name': 'Somapacitan', 'type': 'DRUG', 'description': 'All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan', 'armGroupLabels': ['Mild renal impairment', 'Moderate renal impairment', 'Normal renal function', 'Requiring haemodialysis treatment', 'Severe renal impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}