Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT01091532
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2010-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C526817', 'term': '5-amino-2-((1-n-propyl-1H-imidazol-4-yl)methyl)pentanoic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2010-03-22', 'studyFirstSubmitQcDate': '2010-03-22', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, Rac (=AUCtau (Day 14)/AUCtau (Day 1)), CL/F, Vz/f, Cmin, Cav Urine pharmacokinetics: Aetau & Aetau%, CLR on Day 14', 'timeFrame': '14 days'}, {'measure': 'Time course of changes in prothrombin time, activated partial thromboplastin time, TAFi inhibition, fibrinogen and D-dimer concentrations.', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Phase 1', 'Multiple Dose', 'Safety', 'Toleration', 'Pharmacokinetic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3941010&StudyName=A%20Double%20Blind%2C%20Randomized%203rd%20Party%20Open%2C%20Placebo%20Controlled%2C%20Parallel%20Group%20Multiple%20Oral%20Escalating%20Dose%20Study%20to%20Investigate%20the%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20and%20Pharmacodynamics%20of%20UK-396%2C082%20In%20Healthy%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study in healthy people is to investigate the safety, toleration and time course of UK-396,082 concentration in the blood and any changes in relevant markers of drug effects, following multiple doses given twice daily by mouth for 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* A positive urine drug screen.\n* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT01091532', 'briefTitle': 'A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double Blind, Randomized 3rd Party Open, Placebo Controlled, Parallel Group Multiple Oral Escalating Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UK-396,082 In Healthy Subjects', 'orgStudyIdInfo': {'id': 'A3941010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Subjects will be assigned to receive either UK-396,082 or placebo', 'interventionNames': ['Drug: UK-396,082', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Subjects will be assigned to receive either UK-396,082 or placebo', 'interventionNames': ['Drug: UK-396,082', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Subjects will be assigned to receive either UK-396,082 or placebo', 'interventionNames': ['Drug: UK-396,082', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'Subjects will be assigned to receive either UK-396,082 or placebo', 'interventionNames': ['Drug: UK-396,082', 'Drug: placebo']}], 'interventions': [{'name': 'UK-396,082', 'type': 'DRUG', 'description': '100mg given orally twice daily for 14 days\n\nThe decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.', 'armGroupLabels': ['Cohort 1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'given orally twice daily for 14 days', 'armGroupLabels': ['Cohort 1']}, {'name': 'UK-396,082', 'type': 'DRUG', 'description': '300mg given orally twice daily for 14 days\n\nThe decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.', 'armGroupLabels': ['Cohort 2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'given orally twice daily for 14 days', 'armGroupLabels': ['Cohort 2']}, {'name': 'UK-396,082', 'type': 'DRUG', 'description': '1000mg given orally twice daily for 14 days\n\nThe decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.', 'armGroupLabels': ['Cohort 3']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'given orally twice daily for 14 days', 'armGroupLabels': ['Cohort 3']}, {'name': 'UK-396,082', 'type': 'DRUG', 'description': 'UK-396,082 given orally, once on Days 1 \\& 14, and twice daily on Days 3-13.\n\nThe decision to proceed to the next higher dose will be made jointly by the Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts. Dependent on the emerging safety, tolerability and PK data, Cohort 4 may be recruited to study a higher (or lower) dose of UK-396,082 in order to characterize further the safety, toleration and PK and/or to define the maximum tolerated dose. The dose in Cohort 4 will be selected such that the predicted Cmax will not exceed 46 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.', 'armGroupLabels': ['Cohort 4']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'given orally, once on Days 1 \\& 14, and twice daily on Days 3-13.', 'armGroupLabels': ['Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}