Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 6:32 PM
Study NCT ID:
NCT01504906
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2012-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-11', 'studyFirstSubmitDate': '2012-01-02', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX in terms of maximum concentration (Cmax),time to maximum concentration (tmax) and area under the concentration curve from time zero to infinity (AUC)', 'timeFrame': 'PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours', 'description': 'PK samples will be collected postdose at visits 2,3 and 4'}, {'measure': 'Description of the PK profile for Ticagrelor and its metabolite AR-C124910XX in terms of area under the concentration-time curve from time zero to the last measurable concentration (AUC(0-t)),terminal half-life (t1/2)', 'timeFrame': 'PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours', 'description': 'PK samples will be collected postdose at visit 2,3 and 4'}, {'measure': 'Description of the PK profile for AR-C124910XX : ticagrelor in terms of ratios for Cmax, AUC(0-t), and AUC', 'timeFrame': 'PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours', 'description': 'PK samples will be collected postdose at visit 2,3 and 4'}, {'measure': 'Description of the PK profile for Cyclosporine in terms of Cmax, AUC(0-t), AUC, tmax and t1/2', 'timeFrame': 'PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours', 'description': 'PK samples will be collected postdose at visit 2,3 and 4'}], 'secondaryOutcomes': [{'measure': 'Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables', 'timeFrame': 'Baseline up to 45 days'}]}, 'conditionsModule': {'keywords': ['Phase 1', 'Healthy male volunteers', 'pharmacokinetics', 'cyclosporine', 'ticagrelor', 'Bioavailability (plasma AUC, Cmax, plasma AUC0-t, t1/2λz, tmax)'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '24861133', 'type': 'DERIVED', 'citation': 'Teng R, Kujacic M, Hsia J. Pharmacokinetic interaction study of ticagrelor and cyclosporine in healthy volunteers. Clin Drug Investig. 2014 Aug;34(8):529-36. doi: 10.1007/s40261-014-0205-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of Cyclosporine on the blood levels of Ticagrelor.', 'detailedDescription': 'A Single-Center,Open-Label,Randomized,3-Treatment,3-Period Cross-Over Study to Investigate the Potential Effect of Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Ticagrelor and the Effect of Ticagrelor on the Pharmacokinetics, Safety, and Tolerability of Cyclosporine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed and dated written informed consent prior to any study-specific procedures\n* Healthy male subjects aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture\n\nExclusion Criteria:\n\n* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs\n* A history of hemophilia, von Willebrand's disease, lupus anti-coagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding\n* A personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage, or rectal bleeding within 1 year"}, 'identificationModule': {'nctId': 'NCT01504906', 'briefTitle': 'Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Single-Center,Open-Label,Randomized,3-Treatment,3-Period Cross-Over Study to Investigate the Potential Effect of Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Ticagrelor and the Effect of Ticagrelor on the Pharmacokinetics, Safety, and Tolerability of Cyclosporine', 'orgStudyIdInfo': {'id': 'D5130C00074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor', 'interventionNames': ['Drug: cyclosporine', 'Drug: ticagrelor']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'single dose cyclosporine 600 mg', 'interventionNames': ['Drug: cyclosporine']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'single dose 180 mg ticagrelor', 'interventionNames': ['Drug: ticagrelor']}], 'interventions': [{'name': 'cyclosporine', 'type': 'DRUG', 'description': 'Oral tablets, 600 mg , single dose', 'armGroupLabels': ['A', 'B']}, {'name': 'ticagrelor', 'type': 'DRUG', 'description': 'Oral tablets, 180 mg, single dose', 'armGroupLabels': ['A', 'C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Miriana Kujacic, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Molndal, Sweden AstraZeneca'}, {'name': 'Kelli Craven, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Overland Park US, Quintiles, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}