Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT06140095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C577155', 'term': 'evolocumab'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholesterol metabolism effect', 'timeFrame': '32 hours', 'description': 'Effect of these treatments on markers for cholesterol metabolism, namely lathosterol and campesterol, measured as change from baseline concentration (mg/mmol) per unit time.'}, {'measure': 'Bile acid metabolism effect', 'timeFrame': '32 hours', 'description': 'Effect of these treatments on markers for bile acid metabolism, namely C4; measured as change from baseline concentration (mg/mmol) per unit time.'}, {'measure': 'Bile acid metabolism effect', 'timeFrame': '32 hours', 'description': 'Effect of these treatments on markers for cholesterol and bile acid metabolism, namely bile acids; measured as change from baseline concentration (mikromol/ml) per unit time.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Metabolic Effects of Evolocumab and Atorvastatin']}, 'descriptionModule': {'briefSummary': 'Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* \\>18 years of age\n\nExclusion Criteria:\n\n* Cardiovascular disease\n* Cerebrovascular disease (e.g. stroke, prior aneurysm)\n* Pulmonary disease (e.g. pulmonary hypertension, COPD)\n* Metabolic disease (incl. but not limited to Cushing disease, Diabetes)\n* Renal disease (by Chronic kidney disease criteria)\n* Active inflammatory bowel syndrome\n* Cancer\n* Pregnancy\n* Smoker\n* Any chronic medication use\n* Steroid treatment for the last six months or hormone replacement therapy\n* Coagulopathy\n* Musculoskeletal or neurologic disease\n* Know allergy against any of the studied substances\n* Inclusion in any other concurrent medical research study'}, 'identificationModule': {'nctId': 'NCT06140095', 'briefTitle': 'Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism', 'orgStudyIdInfo': {'id': 'PSM1A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full group', 'description': 'Evolocumab 140 mg subcutaneously. Två months later, repetitive doses of atorvastatin 40 mg once daily.\n\nAfter continued atorvastatin, evolocumab 140 mg is added subcutaneously.', 'interventionNames': ['Drug: Evolocumab']}], 'interventions': [{'name': 'Evolocumab', 'type': 'DRUG', 'otherNames': ['Atorvastatin'], 'description': 'See arm description', 'armGroupLabels': ['Full group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Erik Hoffmann, MD', 'role': 'CONTACT', 'email': 'erik.hoffmann@ki.se', 'phone': '+46 8-517 700 00'}, {'name': 'Mats Eriksson, MD PhD', 'role': 'CONTACT', 'email': 'mats.eriksson@ki.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}