Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-22 @ 9:32 AM
Study NCT ID:
NCT06444204
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to t (AUC0-t)', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Percent of AUC0-inf extrapolated total rilzabrutinib in plasma (%AUCextrap )', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Maximum measured concentration of total rilzabrutinib in plasma (Cmax)', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Elimination Rate Constant of total rilzabrutinib (Kel)', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Apparent Total Clearance of rilzabrutinib in the plasma after extra-vascular administration (CL/F)', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Apparent Volume of Distribution during the Terminal elimination phase after extravascular administration (Vz/F)', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}, {'measure': 'Fraction of unbound drug ( rilzabrutinib) expressed as percent (%fu)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing'}, {'measure': 'Number of Adverse Events (AE) / Serious Adverse Events (SAE)', 'timeFrame': 'From date of signed ICF, up to 9 days after rilzabrutinib dosing'}, {'measure': 'Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities', 'timeFrame': 'Up to 30 hours after rilzabrutinib dosing'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to t (AUC0-t)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing'}, {'measure': 'Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing'}, {'measure': 'Percent of AUC0-inf extrapolated rilzabrutinib metabolites in plasma (%AUCextrap)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing'}, {'measure': 'Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing'}, {'measure': 'Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing'}, {'measure': 'Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing'}, {'measure': 'Elimination Rate Constant of rilzabrutinib metabolites (Kel)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing'}, {'measure': 'Metabolite-to-parent ratio (MRAUC)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing', 'description': 'MRAUC is Based on AUC0-t, corrected for Molecular weights (MW). MRAUC = (AUC0-t,M/AUC0-t,P) x (MW,P/MW,M) where M was metabolite and P was parent.'}, {'measure': 'Metabolite-to-parent ratio (MRCmax)', 'timeFrame': 'Up to 24 hours after rilzabrutinib dosing', 'description': 'MRCmax is based on Cmax, corrected for MW. MRCmax = (Cmax,M/ Cmax,P) x (MW,P/MW,M) where M was metabolite and P was parent.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Function Abnormal', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hepatic Impaired Subjects:\n\n * Non-smoking or light smoker (not exceeding 5 cigarettes per day), adult male or non-pregnant, non-lactating female, 18-75 years of age, inclusive, at screening.\n * Weight ≥ 50 kg, at screening.\n* Healthy Subjects:\n\n * Non-smoking or light smoker (not exceeding 5 cigarettes per day), healthy, adult males and non-pregnant, non-lactating females, 18-75 years of age, inclusive, at screening.\n\nSubject must be matched for age (within ± 10 years), and sex of the matched subject with hepatic impairment.\n\n--Weight ≥ 50 kg at screening.\n\nAdditional inclusion criteria might apply.\n\nExclusion Criteria:\n\n* Hepatic Impaired Subjects:\n\n * Pregnant or lactating female.\n * Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 millimeters of mercury \\[mmHg\\] and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate \\< 45 or \\> 100 beats per minute (bpm). Measurements may be repeated once in order to determine eligibility.\n* Healthy Subjects\n\n * Pregnant or lactating female.\n * Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate \\< 45 or \\> 100 bpm. Measurements may be repeated once in order to determine eligibility.\n\nAdditional exclusion criteria might apply.'}, 'identificationModule': {'nctId': 'NCT06444204', 'briefTitle': 'A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-Label, Phase 1 Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)', 'orgStudyIdInfo': {'id': 'POP17091'}, 'secondaryIdInfos': [{'id': 'U1111-1260-4098', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': 'PRN1008-020', 'type': 'OTHER', 'domain': 'Sanofi Identifier'}, {'id': 'POP17091', 'type': 'OTHER', 'domain': 'Sanofi Identifier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rilzabrutinib: Mild Hepatic Impairment', 'description': 'Subjects with mild Hepatic Impairment (HI)', 'interventionNames': ['Drug: Rilzabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Rilzabrutinib: Moderate Hepatic Impairment', 'description': 'Subjects with moderate Hepatic Impairment (HI)', 'interventionNames': ['Drug: Rilzabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Rilzabrutinib: Healthy-Matched Control', 'description': 'Subjects with normal hepatic function', 'interventionNames': ['Drug: Rilzabrutinib']}], 'interventions': [{'name': 'Rilzabrutinib', 'type': 'DRUG', 'description': 'Rilzabrutinib tablet administered orally', 'armGroupLabels': ['Rilzabrutinib: Healthy-Matched Control', 'Rilzabrutinib: Mild Hepatic Impairment', 'Rilzabrutinib: Moderate Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number: 0002', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number: 0001', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], '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': 'Principia Biopharma, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}