Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT01433458
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2011-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-09-12', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the serum concentration-time curve from time zero to infinity (AUCinf)', 'timeFrame': 'Up to Day 15', 'description': 'Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030'}, {'measure': 'Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)', 'timeFrame': 'Up to Day 15', 'description': 'Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030'}, {'measure': 'Serum concentration at 24 hour (C24h) after administration', 'timeFrame': 'Upto Day 15', 'description': 'Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events, serious adverse events and death', 'timeFrame': 'Day 15', 'description': 'Monitoring of adverse events, serious adverse events and death from screening to end of study'}, {'measure': 'Determination of the presence and quantification of anti-RLX030 antibodies', 'timeFrame': 'Day 1 (prior to administration) and Day 15 end of study', 'description': 'Blood will be collected and serum analyzed for the presence of antiRLX030 antibodies. Anti-RLX030 antibodies will be evaluated in serum in a validated four-tiered assay approach'}, {'measure': 'Mean residence time [MRT] of RLX030', 'timeFrame': 'screening, days 1, 2, 3, 4 and 15', 'description': 'Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030'}, {'measure': 'Terminal elimination half life (T ½) of RLX030', 'timeFrame': 'screening, days 1, 2, 3, 4 and 15', 'description': 'Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030'}, {'measure': 'Systemic clearance of RLX030 from serum (CL)', 'timeFrame': 'screening, days 1, 2, 3, 4 and 15', 'description': 'Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030'}, {'measure': 'Volume of distribution at steady state (Vss)', 'timeFrame': 'screening, days 1, 2, 3, 4 and 15', 'description': 'Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030'}]}, 'conditionsModule': {'keywords': ['Hepatic impairment', 'healthy volunteers', 'RLX030', 'pharmacokinetics'], 'conditions': ['Hepatic Impairment']}, 'referencesModule': {'references': [{'pmid': '25511105', 'type': 'DERIVED', 'citation': 'Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45. doi: 10.1111/bcp.12572.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7565', 'label': 'Results for CRLX030A2101 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects.\n\n20 to 24 patients and 20 to 24 healthy subjects will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* All subjects:\n\n • Female subjects must be of non-child bearing potential OR use an effective method of contraception and sexually active males must use a condom during intercourse while taking the drug and for 5 half-lives after stopping treatment\n* Subjects with hepatic impairment:\n\n * Subjects must have either mild, moderate or severe hepatic impairment\n\nExclusion criteria:\n\n* All subjects\n\n * Hepatic impairment due to non-liver disease\n * Use of other investigational drugs at time of enrollment\n * History of malignancy of any organ system\n * Donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to initial dosing\n * Hemoglobin levels below 10.0 g/dL at screening or baseline\n* Subjects with hepatic impairment:\n\n * Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk\n * Treatment with any cytostatic drug, vasodilator, autonomic alpha blocker or B2 agonist\n * Any surgical or medical condition other than hepatic impairment which might significantly alter the distribution or excretion of drugs\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01433458', 'briefTitle': 'Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Single-dose, Open-label Parallel Study to Assess the Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects', 'orgStudyIdInfo': {'id': 'CRLX030A2101'}, 'secondaryIdInfos': [{'id': '2011-001596-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RLX030: Group 1 mild hepatic impairment', 'description': 'Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030', 'interventionNames': ['Drug: RLX030A']}, {'type': 'EXPERIMENTAL', 'label': 'RLX030: Group 2 moderate hepatic impairment', 'description': 'Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030', 'interventionNames': ['Drug: RLX030A']}, {'type': 'EXPERIMENTAL', 'label': 'RLX030: Group 3 severe hepatic impairment', 'description': 'Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030', 'interventionNames': ['Drug: RLX030A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RLX030: Group 4 - healthy volunteers', 'description': 'Participants will receive a single IV 24 hour infusion of RLX030. This group will consist of 3 sub-groups to match patients of groups 1, 2and 3.', 'interventionNames': ['Drug: RLX030A']}], 'interventions': [{'name': 'RLX030A', 'type': 'DRUG', 'description': 'RLX030 is administered as a continuous 24 hour infusion', 'armGroupLabels': ['RLX030: Group 1 mild hepatic impairment', 'RLX030: Group 2 moderate hepatic impairment', 'RLX030: Group 3 severe hepatic impairment', 'RLX030: Group 4 - healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-67269', 'city': 'Grünstadt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.56302, 'lon': 8.16279}}, {'zip': '115419', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}