Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-01 @ 2:27 AM
Study NCT ID:
NCT01901133
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2013-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540278', 'term': 'enzalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-12', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of pharmacokinetics measured by AUC0-inf following single dose of MDV3100', 'timeFrame': 'Day 1 through Day 50 (25 times)', 'description': 'Area under the plasma concentration - time curve extrapolated to infinity (AUC0-inf) in subjects with mild and moderate hepatic impairment to matched control subjects with normal hepatic function.'}, {'measure': 'Assessment of pharmacokinetics measured by Cmax following single dose of MDV3100', 'timeFrame': 'Day 1 through Day 50 (25 times)', 'description': 'Maximum concentration (observed) (Cmax) in subjects with mild and moderate hepatic impairment to matched control subjects with normal hepatic function.'}], 'secondaryOutcomes': [{'measure': 'Composite of pharmacokinetics following single dose of MDV3100', 'timeFrame': 'Day 1 through Day 50 (25 times)', 'description': 'Measured by Time to attain Cmax (tmax), AUC up to last quantifiable concentration (AUC0-last), Apparent terminal elimination half life (t1/2), Apparent volume of distribution during the terminal phase after extra vascular dosing (Vz/F), Apparent total body clearance after extra vascular dosing (CL/F), Cmax, t1/2, AUC0-inf, Unbound maximum concentration (observed) (Cmax,u), Unbound AUC extrapolated to infinity (AUC0-inf,u), Unbound apparent total body clearance after extra vascular dosing (CLu/F), Unbound apparent volume of distribution during the terminal phase after extra vascular dosing (Vz,u/F), Fraction unbound (fu).'}, {'measure': 'Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG) and clinical safety laboratory and adverse events', 'timeFrame': 'Day 1 through Day 50', 'description': 'For hepatic impaired subjects, additional Child-Pugh classification will be performed after MDV3100 administration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'MDV3100', 'Hepatic Impairment', 'Kidney Diseases', 'Xtandi', 'enzalutamide'], 'conditions': ['Pharmacokinetics of MDV3100', 'Healthy Subjects', 'Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '25917876', 'type': 'DERIVED', 'citation': 'Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects.\n\nThe study will consist of two treatment arms. Arm A will assess the influence of mild hepatic impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and age-matched subjects with normal hepatic function.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All subjects must meet all of the following inclusion criteria:\n\n * Subject must be non-fertile, i.e., surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies\n * Body Mass Index (BMI) of at least 18.5 and no greater than 34.0 kg/m2.\n* Subjects with mild or moderate hepatic impairment must also meet the following inclusion criteria:\n\n * Child-Pugh classification Class A (mild, 5 or 6 points) or Class B (moderate, 7 to 9 points) liver function impairment.\n\nExclusion Criteria:\n\n* All subjects must not have any of the following characteristics:\n\n * Known or suspected hypersensitivity to MDV3100 or any components of the formulation used.\n * History of seizure or any condition that may predispose to seizure. Also history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Day 1 visit).\n * Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).\n * Abnormal pulse and/or blood pressure (BP) measurements at the pre-study visit as follows: Pulse \\<40 or \\>90 bpm; mean systolic BP \\>160 mmHg; mean diastolic BP \\>100 mmHg (BP measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured\n * A QTcF interval of \\>450 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).\n * Significant renal dysfunction (creatinine clearance below 60 mL/min, estimated according to the method of modification of diet in renal disease (MDRD) formula).\n * Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.\n * Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life.\n* For subjects with normal hepatic function:\n\n * Regular use of any prescribed or OTC (over-the-counter) drugs, which includes vitamins, natural and herbal remedies (e.g. St John's wort) and food supplements in the 4 weeks prior to admission to the Clinical Unit and use of any drugs in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day).\n * Positive serology test for HBsAg, anti HAV (IgM), anti-HCV, anti-HIV-1 or anti-HIV-2.\n* For subjects with mild or moderate hepatic impairment:\n\n * Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period. (e.g. advanced ascites, infection of ascites, fever, active gastrointestinal bleeding).\n * Change in dose regimen of medically required medication within the last two weeks before pre-study examination (allowed co-medication in patients), and/or the use of unallowed co-medication in the 3 weeks prior to admission to the clinical unit (not allowed: any known hepatic enzyme altering agents or compounds known to restrict metabolism).\n * Presence of a hepatocellular carcinoma, or an acute liver disease caused by an infection or drug toxicity.\n * Severe portal hypertension or surgical porto-systemic shunts, including TIPSS (Transjugular intrahepatic portosystemic shunt).\n * Biliary obstruction or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver.\n * Signs of significant hepatic encephalopathy (Hepatic encephalopathy score \\>2).\n * Severe ascites and/or pleural effusion\n * Esophageal variceal bleeding in the medical history.\n * Thrombocyte level below 40x109/L and /or hemoglobin below 90 g/L.\n * Previous liver transplantation.\n * Positive serology test for, anti HAV (IgM), anti-HIV-1 or anti-HIV-2."}, 'identificationModule': {'nctId': 'NCT01901133', 'briefTitle': 'Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MDV3100 in Male Subjects With Mild or Moderate Hepatic Impairment and Normal Hepatic Function', 'orgStudyIdInfo': {'id': '9785-CL-0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: Mild hepatic impairment subjects + control', 'interventionNames': ['Drug: MDV3100']}, {'type': 'EXPERIMENTAL', 'label': 'B: Moderate hepatic impairment subjects + control', 'interventionNames': ['Drug: MDV3100']}], 'interventions': [{'name': 'MDV3100', 'type': 'DRUG', 'otherNames': ['Xtandi', 'enzalutamide'], 'description': 'Oral', 'armGroupLabels': ['A: Mild hepatic impairment subjects + control', 'B: Moderate hepatic impairment subjects + control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Arensia', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}], 'overallOfficials': [{'name': 'Operation Senior Research Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe B.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medivation, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}