Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT01034202
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2009-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C558310', 'term': 'NNC126-0083'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'after administration of a single dose of NNC126-0083'}], 'secondaryOutcomes': [{'measure': 'Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083', 'timeFrame': '0-168 hours after trial drug administration'}, {'measure': 'Number of injection site reactions', 'timeFrame': 'after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®'}, {'measure': 'IGF-I (Insulin-like Growth Factor I) levels', 'timeFrame': 'after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Disorder', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '20427496', 'type': 'RESULT', 'citation': 'Rasmussen MH, Bysted BV, Anderson TW, Klitgaard T, Madsen J. Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile. J Clin Endocrinol Metab. 2010 Jul;95(7):3411-7. doi: 10.1210/jc.2009-2813. Epub 2010 Apr 28.'}], '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 (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, non-smoking male subjects\n* Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive\n* Body weight max. 100 kg\n\nExclusion Criteria:\n\n* A history 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 diseases\n* Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies\n* Positive result of test for HIV (Human Immunodeficiency Virus) antibodies\n* Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the physician\n* Clinically significant abnormal ECG (ElectroCardioGram) at screening as evaluated by the physician\n* A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug/alcohol screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits)\n* Habitual smoking, i.e daily smoking or more than 7 cigarettes/week\n* Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of their general practitioner or the Investigator should not participate in the trial\n* Surgery or trauma with significant blood loss within the last 2 months prior to dosing'}, 'identificationModule': {'nctId': 'NCT01034202', 'briefTitle': 'Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'NN8630-1822'}, 'secondaryIdInfos': [{'id': '2007-001255-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083', 'interventionNames': ['Drug: NNC126-0083', 'Drug: Norditropin® SimpleXx®']}, {'type': 'EXPERIMENTAL', 'label': 'Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083', 'interventionNames': ['Drug: NNC126-0083', 'Drug: Norditropin® SimpleXx®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Norditropin® SimpleXx® 0.02 mg/kg + placebo', 'interventionNames': ['Drug: placebo', 'Drug: Norditropin® SimpleXx®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Norditropin® SimpleXx® 0.04 mg/kg + placebo', 'interventionNames': ['Drug: placebo', 'Drug: Norditropin® SimpleXx®']}, {'type': 'EXPERIMENTAL', 'label': 'NNC126-0083', 'interventionNames': ['Drug: NNC126-0083']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'NNC126-0083', 'type': 'DRUG', 'description': 'One of five dose levels administered subcutaneously (under the skin)', 'armGroupLabels': ['Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083', 'Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083']}, {'name': 'Norditropin® SimpleXx®', 'type': 'DRUG', 'description': 'One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)', 'armGroupLabels': ['Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083', 'Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo comparator', 'armGroupLabels': ['Norditropin® SimpleXx® 0.02 mg/kg + placebo', 'Norditropin® SimpleXx® 0.04 mg/kg + placebo', 'Placebo']}, {'name': 'NNC126-0083', 'type': 'DRUG', 'description': 'One of three dose levels administered subcutaneously (under the skin)', 'armGroupLabels': ['NNC126-0083']}, {'name': 'Norditropin® SimpleXx®', 'type': 'DRUG', 'description': 'One of two dose levels, followed by placebo, administered subcutaneously (under the skin)', 'armGroupLabels': ['Norditropin® SimpleXx® 0.02 mg/kg + placebo', 'Norditropin® SimpleXx® 0.04 mg/kg + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], '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'}}}}