Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT00176020
Status:
UNKNOWN
Last Update Posted:
2006-03-15
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'lastUpdateSubmitDate': '2006-03-14', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2006-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['nicotinic acid', 'flush symptom', 'pharmacodynamic', 'pharmacokinetic'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment, 3--way crossover. Subjects will be randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:\n\n* Treatment A: 500 mg nicotinic acid (Niacor(R))\n* Treatment B: Niacor(R) Placebo\n\nEach trial period will last one day, there will be a wash-out period of at least 2 days between each trial period. Five to seven days after study day 1 of trial period 3 there will be a final safety examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good state of health physically and mentally\n\nExclusion Criteria:\n\n* Treatment with any other investigational product in the last 60 days before the day of randomization into the study\n* Regular use of medication in the last 60 days before the day of randomization into the study except of oral contraceptives in female participants\n* Treatment in the 60 days before the day of randomization into the study with any drug known to have a well-defined potential for toxicity to a major organ, or any substance which is known to induce or inhibit hepatic drug metabolism (including general anesthetics)\n* Any drug intake (including over-the-counter remedies) in the 2 weeks before the day of randomization into the study, unless the investigator considers a drug intake to be clinically irrelevant for the purpose of this study\n* Any acute or chronic illness or clinically relevant findings in the pre-study examination\n* Presence, history or sequelae of gastrointestinal (e.g. peptic ulcer), liver or kidney disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs\n* History of hypersensitivity to the investigational product\n* History or presence of abnormalities of the vascular bed\n* History or presence of a dermatologic disease or skin lesions, particular in the area chosen for flush measurement\n* History of allergy or hypersensitivity to other drugs or to food constituents\n* History of other allergic diseases or hypersensitivity, unless the investigator considers it to be clinically irrelevant for the purpose of this study\n* Blood donation of \\> 400 ml in the 60 days before the day of randomization into the study\n* Smoking\n* Positive result in urine screen for drugs of abuse or in alcohol breath test\n* Known or suspected to be drug-dependent, including consumption of \\> 30 g alcohol per day\n* Pregnancy or lactation\n* Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol\n* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study\n* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study'}, 'identificationModule': {'nctId': 'NCT00176020', 'briefTitle': 'Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Double-Blind, Randomized, Placebo-Controlled, Single-Center, 2 Treatment, 3-Way Crossover Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 Mg Nicotinic Acid as Tablets in Healthy Subjects', 'orgStudyIdInfo': {'id': '2005-003234-18'}, 'secondaryIdInfos': [{'id': 'K115'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'nicotinic acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Brigitte Tubach, R:N:', 'role': 'CONTACT', 'email': 'brigitte.tubach@med.uni-heidelberg.de'}], 'overallOfficials': [{'name': 'Gerd Mikus, MD Bsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department Internal Medicine VI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}}}}