Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-01-07 @ 4:27 AM
Study NCT ID:
NCT00820794
Status:
WITHDRAWN
Last Update Posted:
2015-03-05
First Post:
2009-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore']}, 'interventionBrowseModule': {'meshes': [{'id': 'D008094', 'term': 'Lithium'}, {'id': 'C583768', 'term': 'imagabalin'}], 'ancestors': [{'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2009-01-09', 'studyFirstSubmitQcDate': '2009-01-09', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lithium pharmacokinetic endpoints: area under curve from 0 to infinity (AUCinf), area under curve from 0 to last quantifiable concentration (AUClast), half-life (T1/2), and maximum serum concentration (Cmax).', 'timeFrame': '10 days'}, {'measure': 'The nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; clinical safety lab; 12-lead ECG; and vital signs will be monitored in this study.', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'No Secondary Outcomes', 'timeFrame': 'No Secondary Outcomes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug-drug interaction, lithium, PD 0332334, pharmacokinetics'], 'conditions': ['Generalized Anxiety Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361034&StudyName=A%20Phase%201%20Study%20To%20Estimate%20The%20Effects%20Of%20PD%200332334%20On%20Lithium%20Pharmacokinetics%20In%20Healthy%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.', 'detailedDescription': 'Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and/or females\n* Age from 21 to 55 (inclusive)\n* BMI ranges from 18 to 30 kg/m2\n\nExclusion Criteria:\n\n* Previous participation in a PD 332334 study\n* Pregnant or nursing females\n* Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)'}, 'identificationModule': {'nctId': 'NCT00820794', 'briefTitle': 'A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects', 'orgStudyIdInfo': {'id': 'A5361034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1a', 'description': 'Subjects are treated with single dose lithium first. Then after at least 7 day washout, the subjects start PD 0332334 treatment from day 1 to day 9. At day 4 of PD 0332334 treatment, single dose lithium is given to subjects.', 'interventionNames': ['Drug: Lithium', 'Drug: PD 0332334']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1b', 'description': 'Subjects are treated with PD 0332334 from day 1 to 9 and a single dose of lithium is given at day 4. After at least 7 day washout, the subjects are treated with single dose of lithium.', 'interventionNames': ['Drug: Lithium', 'Drug: PD 0332334']}], 'interventions': [{'name': 'Lithium', 'type': 'DRUG', 'description': '300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment', 'armGroupLabels': ['Cohort 1a']}, {'name': 'PD 0332334', 'type': 'DRUG', 'otherNames': ['imagabalin'], 'description': '225 mg q12h PD 0332334, oral, 9 days treatment', 'armGroupLabels': ['Cohort 1a']}, {'name': 'Lithium', 'type': 'DRUG', 'description': '300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout', 'armGroupLabels': ['Cohort 1b']}, {'name': 'PD 0332334', 'type': 'DRUG', 'description': '225 mg q12h PD 0332334, oral, 9 days treatment', 'armGroupLabels': ['Cohort 1b']}]}, 'contactsLocationsModule': {'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.'}}}}