Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00784420
Status:
COMPLETED
Last Update Posted:
2008-11-18
First Post:
2008-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Interaction Study Between Raltegravir And UK-453,061
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C531151', 'term': 'UK 453,061'}, {'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-17', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-11-03', 'lastUpdatePostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12', 'timeFrame': '11 days'}, {'measure': 'UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24', 'timeFrame': '11 days'}], 'secondaryOutcomes': [{'measure': 'Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h', 'timeFrame': '11 days'}, {'measure': 'Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments', 'timeFrame': '11 days'}, {'measure': 'UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h', 'timeFrame': '11 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Interaction, Pharmacokinetics'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271019&StudyName=Drug%20Interaction%20Study%20Between%20Raltegravir%20And%20UK-453%2C061', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the effect of steady state raltegravir on the steady state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state pharmacokinetics of raltegravir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy male and/or female subjects between the ages of 18 and 55 years, inclusive; Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \\>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.\n\nExclusion Criteria:\n\nEvidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.'}, 'identificationModule': {'nctId': 'NCT00784420', 'briefTitle': 'Drug Interaction Study Between Raltegravir And UK-453,061', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects', 'orgStudyIdInfo': {'id': 'A5271019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'UK-453,061', 'interventionNames': ['Drug: UK-453,061']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Raltegravir', 'interventionNames': ['Drug: Raltegravir']}, {'type': 'EXPERIMENTAL', 'label': 'UK-453,061 plus Raltegravir', 'interventionNames': ['Drug: UK-453,061', 'Drug: Raltegravir']}], 'interventions': [{'name': 'UK-453,061', 'type': 'DRUG', 'description': 'UK-453,061 1000 mg once daily for 10 days', 'armGroupLabels': ['UK-453,061 plus Raltegravir']}, {'name': 'UK-453,061', 'type': 'DRUG', 'description': 'UK-453,061 1000 mg once daily for 10 days', 'armGroupLabels': ['UK-453,061']}, {'name': 'Raltegravir', 'type': 'DRUG', 'description': 'Raltegravir 400 mg twice daily for 10 days', 'armGroupLabels': ['Raltegravir']}, {'name': 'Raltegravir', 'type': 'DRUG', 'description': 'Raltegravir 400 mg twice daily for 10 days', 'armGroupLabels': ['UK-453,061 plus Raltegravir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511-5473', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], '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.'}}}}