Ignite Creation Date:
2025-12-25 @ 1:00 AM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT01916993
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2013-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603978', 'term': 'valbenazine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2013-08-02', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854', 'timeFrame': '45 minutes prior to NBI-98854 dosing, and 15, 30, 45 minutes, and 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose'}, {'measure': 'Number of Participants with Adverse Events following dosing with NBI-98854', 'timeFrame': 'Up to 36 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 to 75 years of age.\n* Healthy volunteers must be in good general health.\n* Subjects with hepatic impairment must be judged to be in stable condition.\n* Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.\n* Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeeding.\n* Have a body mass index (BMI) of 18 to 40 kg/m2 (both inclusive).\n\nExclusion Criteria:\n\n* Report more than two alcoholic beverages daily or more than 14 alcoholic beverages weekly withing 7 days of study start.\n* Have a known history of neuroleptic malignant syndrome.\n* Have a positive human immunodeficiency virus (HIV) antibody result at screening or have a history of positive result.\n* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.\n* Have an allergy, hypersensitivity, or intolerance to tetrabenazine.\n* Had a blood loss greater than or equal to 500 mL or donated blood within 56 days of study start.\n* Have had previous exposure with NBI-98854.'}, 'identificationModule': {'nctId': 'NCT01916993', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild, Moderate, or Severe Hepatic Insufficiency', 'orgStudyIdInfo': {'id': 'NBI-98854-1303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers', 'description': 'single dose of NBI-98854 50 mg capsule', 'interventionNames': ['Drug: NBI-98854 50 mg capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impairment', 'description': 'single dose of NBI-98854 50 mg capsule', 'interventionNames': ['Drug: NBI-98854 50 mg capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment', 'description': 'single dose of NBI-98854 50 mg capsule', 'interventionNames': ['Drug: NBI-98854 50 mg capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Hepatic Impairment', 'description': 'single dose of NBI-98854 50 mg capsule', 'interventionNames': ['Drug: NBI-98854 50 mg capsule']}], 'interventions': [{'name': 'NBI-98854 50 mg capsule', 'type': 'DRUG', 'armGroupLabels': ['Healthy Volunteers', 'Mild Hepatic Impairment', 'Moderate Hepatic Impairment', 'Severe Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'DaVita Clinical Research', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Davita Clinical Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': "Chris O'Brien, MD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurocrine Biosciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}