Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-08 @ 10:34 AM
Study NCT ID:
NCT00620802
Status:
COMPLETED
Last Update Posted:
2008-08-26
First Post:
2008-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamics of CGT 2168 Compared With Plavix®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-22', 'studyFirstSubmitDate': '2008-02-12', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of this study is inhibition of platelet aggregation (IPA) based on maximum platelet aggregation (MPA) to 5 and 20 µM ADP after 7 days daily dosing with CGT-2168 compared to Plavix®.', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Residual aggregation, measured 10 min after the addition of 20 and 5 µM ADP, after 7 days daily dosing with CGT 2168 compared to Plavix®.', 'timeFrame': '7 days'}, {'measure': 'Plasma PK measures of clopidogrel (parent drug and carboxylic acid metabolite) with CGT 2168 compared to Plavix®.', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Platelet function testing', 'Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix® (clopidogrel, 75 mg).\n\nHealthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period, subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix® in the order determined by the randomization schedule. Each period of dose administration will be separated by a two-week washout period. Study exit will occur 1 week after Dosing Period 2. The expected total duration of participation is 8 weeks (56 days), including a screening visit on or within 21 days prior to enrollment.\n\nOn the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel parent and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1 and pre-dose and serially after dosing on Day 7.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females. Women of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use two methods of effective barrier contraception, or a hormonal contraceptive to prevent pregnancy throughout the study.\n* Able to comply with study procedures, which includes returning to the Phase I unit for all scheduled visits and procedures.\n* Abstinence from tobacco use (including smoking cessation products containing nicotine) for 90 days prior to study entry, with agreement to abstain from tobacco/nicotine use throughout the study.\n* Agreement to abstain from alcohol and caffeine ingestion from 72 h before dosing and throughout each dosing period.\n* Able to give informed consent, and subject has signed and dated a written consent form approved by the IRB.\n\nExclusion Criteria:\n\n* Hypersensitivity to clopidogrel, omeprazole, or related drugs including inactive ingredients.\n* BMI (body mass index) outside the range of 19-30 kg/m2.\n* At screening, body weight less than 50 kg if male or 45 kg if female.\n* Clinically significant abnormal findings on physical examination, clinical laboratory tests or ECG at screening.\n* History of hypertension or 5-minute sitting screening BP ≥160/100 mmHg on measurements repeated twice.\n* History of diabetes mellitus, renal failure, acute or chronic liver disease, including acute or chronic hepatitis, or cirrhosis.\n* Positive HIV-1 antibody, hepatitis B surface antigen or hepatitis C antibody screening test.\n* History of any clinically significant medical or psychiatric condition.\n* Difficulty in swallowing medication, or any known or suspected gastrointestinal abnormality that may affect drug absorption.\n* Participation in a previous clinical trial within 30 days prior to enrollment (check-in on Day -1 for Visit 2).\n* Blood donation of ≥ 1 pint within 30 days or plasma donation within 14 days prior to enrollment (check-in on Day -1 for Visit 2).\n* Use of any prescription or over-the-counter medications or ingestion of herbal drugs/dietary supplements including vitamins and minerals within 14 days prior to enrollment (check-in on Day -1 for Visit 2). Hormonal contraceptives are allowed.\n* Subject is not willing to refrain from drinking grapefruit juice or eating grapefruit throughout study participation.\n* Subject is an active illicit drug user or has a history of illicit drug use within the previous 12 months.'}, 'identificationModule': {'nctId': 'NCT00620802', 'briefTitle': 'Pharmacodynamics of CGT 2168 Compared With Plavix®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cogentus Pharmaceuticals'}, 'officialTitle': 'A Phase I, Open-Label, Randomized, Multiple-Dose, Two-Way Crossover Study of the Pharmacodynamics of CGT 2168 Compared With Plavix®', 'orgStudyIdInfo': {'id': 'CG106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg)', 'interventionNames': ['Drug: CGT-2168']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Plavix (clopidogrel 75 mg)', 'interventionNames': ['Drug: Plavix']}], 'interventions': [{'name': 'CGT-2168', 'type': 'DRUG', 'description': '(CGT-2168, one capsule each daily)', 'armGroupLabels': ['A']}, {'name': 'Plavix', 'type': 'DRUG', 'description': '(clopidogrel, 75 mg)', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Quintiles Phase I Services', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Pablo Lapuerta, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cogentus Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cogentus Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Pablo Lapuerta, MD', 'oldOrganization': 'Cogentus Pharmaceuticals'}}}}