Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-11 @ 2:12 PM
Study NCT ID:
NCT03138759
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probenecid on Pexidartinib Pharmacokinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600259', 'term': 'pexidartinib'}, {'id': 'D011339', 'term': 'Probenecid'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is an open-label, 2-treatment sequence, 2-period, crossover study with a washout between doses and treatment periods'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-05-01', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'predose to 312 hours post dose', 'description': 'Maximum concentration of the drug and its metabolite in plasma'}, {'measure': 'Time to Maximum Concentration (Tmax)', 'timeFrame': 'within 312 hours post dose', 'description': 'Time at which the maximum concentration is reached'}, {'measure': 'Area under the curve to the last quantifiable measurement (AUClast)', 'timeFrame': 'within 312 hours post dose', 'description': 'Area under the drug concentration time curve from the first measurement to the last'}], 'secondaryOutcomes': [{'measure': 'Number of participants experiencing an adverse event', 'timeFrame': 'within 312 hours post dose', 'description': 'Total number of participants experiencing any adverse event'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics in Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '36264536', 'type': 'DERIVED', 'citation': 'Zahir H, Greenberg J, Shuster D, Hsu C, Watanabe K, LaCreta F. Evaluation of Absorption and Metabolism-Based DDI Potential of Pexidartinib in Healthy Subjects. Clin Pharmacokinet. 2022 Nov;61(11):1623-1639. doi: 10.1007/s40262-022-01172-9. Epub 2022 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to assess the effect of probenecid on the pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.\n\nSecondary objectives are to assess the safety and tolerability of pexidartinib alone and in combination with probenecid.\n\nParticipants will be confined to the clinic for approximately 32 days. Blood samples will be collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h) post dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Is a healthy, nonsmoking person with a body mass index of 18 kg/m2 to 30 kg/m2 (inclusive) at Screening\n* Is willing to be confined at the clinic for approximately 32 days\n* Is surgically sterile or a naturally postmenopausal female and not lactating, or a male who agrees to use double barrier methods of contraception and avoid donating sperm from Check-in until 90 d after the final dose of pexidartinib\n\nExclusion Criteria:\n\n* Has any history or condition, per protocol or in the opinion of the investigator, that might compromise the participant's safety, their ability to complete the trial, and or analysis of results"}, 'identificationModule': {'nctId': 'NCT03138759', 'briefTitle': 'Effect of Probenecid on Pexidartinib Pharmacokinetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'An Open-label, Randomized, 2-treatment, 2-period, Crossover Study to Evaluate the Effect of Probenecid on the Pharmacokinetics of Pexidartinib in Healthy Subjects', 'orgStudyIdInfo': {'id': 'PL3397-A-U122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pexidartinib then Probenecid', 'description': 'Participants receive Sequence AB: Treatment A (pexidartinib) first, then Treatment B (probenecid), with a washout period between them', 'interventionNames': ['Drug: Pexidartinib', 'Drug: Probenecid']}, {'type': 'EXPERIMENTAL', 'label': 'Probenecid then Pexidartinib', 'description': 'Participants receive Sequence BA: Treatment B (probenecid) first, then Treatment A (pexidartinib), with a washout period between them', 'interventionNames': ['Drug: Pexidartinib', 'Drug: Probenecid']}], 'interventions': [{'name': 'Pexidartinib', 'type': 'DRUG', 'otherNames': ['Treatment A'], 'description': 'Orally, on Day 2', 'armGroupLabels': ['Pexidartinib then Probenecid', 'Probenecid then Pexidartinib']}, {'name': 'Probenecid', 'type': 'DRUG', 'otherNames': ['Treatment B'], 'description': 'Orally, on Day 2', 'armGroupLabels': ['Pexidartinib then Probenecid', 'Probenecid then Pexidartinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Worldwide Clinical Trials Early Phase Services', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Clinical Study Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}