Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT05806567
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2023-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718240', 'term': 'belumosudil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-last)- Parts 1,2, and 3 (victim drugs)', 'timeFrame': 'Multiple timepoints up to approximately 15 days', 'description': 'Area under the curve from time 0 to the time of last measurable concentration'}, {'measure': 'AUC(0-inf)- Parts 1,2, and 3 (victim drugs', 'timeFrame': 'Multiple timepoints up to approximately 15 days', 'description': 'Area under the curve from time 0 extrapolated to infinity'}], 'secondaryOutcomes': [{'measure': 'Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)', 'timeFrame': 'Multiple timepoints up to approximately 15 days', 'description': 'Time of maximum observed concentration.'}, {'measure': 'Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)', 'timeFrame': 'Multiple timepoints up to approximately 15 days', 'description': 'Maximum observed concentration'}, {'measure': 'T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)', 'timeFrame': 'Multiple timepoints up to approximately 15 days', 'description': 'Terminal elimination half-life'}, {'measure': 'AUC(0-last)-Part 1 (victim metabolite)', 'timeFrame': 'Multiple timepoints up to approximately 10 days'}, {'measure': 'AUC(0-inf)- Part 1 (metabolite of victim drug)', 'timeFrame': 'Multiple timepoints up to approximately 10 days'}, {'measure': 'Tmax- Part 1(metabolite of victim drug)', 'timeFrame': 'Multiple timepoints up to approximately 10 days'}, {'measure': 'Cmax- Part 1 (metabolite of victim drug)', 'timeFrame': 'Multiple timepoints up to approximately 10 days'}, {'measure': 'T1/2- Part 1 (metabolite of victim drug)', 'timeFrame': 'Multiple timepoints up to approximately 10 days'}, {'measure': 'AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites)', 'timeFrame': 'Multiple timepoints up to approximately 15 days'}, {'measure': 'Area under the curve for the defined interval between doses (tau) [AUC(0 tau)] - Parts 1, 2, and 3', 'timeFrame': 'Multiple timepoints up to approximately 15 days', 'description': 'Area under the curve for the defined interval between doses (tau)'}, {'measure': 'Number of participants with adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Up to 30 days after the administration of last dose of study drug i.e., up to approximately 43 days', 'description': 'To provide additional safety and tolerability information for belumosudil by assessing: AEs, vital signs, ECGs, physical examinations and laboratory safety tests following administration of the three victim drugs alone and in combination with belumosudil.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune System Disorder', 'Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sanofi.trialsummaries.com/Study/StudyDetails?id=25274&tenant=MT_SNY_9011', 'label': 'INT17676 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and pharmacokinetics (PK) effect of belumosudil on the uridine diphosphate glucuronosyltransferase (UGT)1A1 (Part 1), P glycoprotein (P-gp) (Part 2) and breast cancer resistance protein (BCRP)/organic anion transporting polypeptide (OATP)1B1 (Part 3) inhibition in the fed state in healthy male subjects.', 'detailedDescription': 'Part 1: The estimated time from screening until the follow-up phone call is approximately 6 weeks per subject.\n\nPart 2: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subject.\n\nPart 3: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male participants aged 18 to 55 years old\n* Must agree to use an adequate method of contraception\n* Must be able to understand and provide a written informed consent\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.\n* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.\n* Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.\n* Failure to satisfy the investigator of fitness to participate for any other reason.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT05806567', 'briefTitle': 'A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Three-part, Sequential, Non-randomized, Open-label Study Designed to Evaluate the Effect of Oral Belumosudil on UGT1A1, P-gp, BCRP and OATP1B1 Inhibition in the Fed State in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'INT17676'}, 'secondaryIdInfos': [{'id': 'U1111-1277-6732', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'Belumosudil + UGT1A1 victim drug administered in the fed state', 'interventionNames': ['Drug: Belumosudil', 'Drug: UGT1A1 victim drug']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Belumosudil + P-gp victim drug administered in the fed state', 'interventionNames': ['Drug: Belumosudil', 'Drug: P-gp victim drug']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3', 'description': 'Belumosudil + OATP1B1/BCRP victim drug administered in the fed state', 'interventionNames': ['Drug: Belumosudil', 'Drug: OATP1B1/BCRP victim drug']}], 'interventions': [{'name': 'Belumosudil', 'type': 'DRUG', 'otherNames': ['REZUROCK/KD025/SAR445761'], 'description': 'Pharmaceutical form: Tablet; Route of administration: Oral', 'armGroupLabels': ['Part 1', 'Part 2', 'Part 3']}, {'name': 'UGT1A1 victim drug', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet; Route of administration: Oral', 'armGroupLabels': ['Part 1']}, {'name': 'P-gp victim drug', 'type': 'DRUG', 'description': 'Pharmaceutical form: Capsule; Route of administration: Oral', 'armGroupLabels': ['Part 2']}, {'name': 'OATP1B1/BCRP victim drug', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet; Route of administration: Oral', 'armGroupLabels': ['Part 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number: 8400001', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kadmon, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}