Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT01741493
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2012-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613732', 'term': 'upadacitinib'}, {'id': 'C479163', 'term': 'tofacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of participants with Adverse Events', 'timeFrame': 'From first dose up to 28 days after the last dose of study drug'}, {'measure': 'Vital Signs', 'timeFrame': 'From first dose up to 28 days after the last dose of study drug', 'description': 'Blood pressure, pulse rate and body temperature'}, {'measure': 'Clinical Lab testing', 'timeFrame': 'From date of first dose up to 28 days after the last dose of study drug', 'description': 'Hematology, Chemistry, and Urinalysis'}, {'measure': 'Electrocardiogram (ECG)', 'timeFrame': 'Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose', 'description': 'ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration'}, {'measure': 'Pharmacokinetics of ABT-494', 'timeFrame': 'Prior to first dose up to 72 hours after the last dose of ABT-494', 'description': 'Cmax, Tmax, AUC, elimination rate constant and half-life'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of Methotrexate', 'timeFrame': 'Prior to first dose up to 48 hours after the last dose of methotrexate', 'description': 'Cmax, Tmax, AUC, elimination rate constant and half-life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Methotrexate', 'Tolerability', 'Pharmacokinetics', 'Safety', 'Tofacitinib'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '27272171', 'type': 'RESULT', 'citation': 'Mohamed MF, Camp HS, Jiang P, Padley RJ, Asatryan A, Othman AA. Pharmacokinetics, Safety and Tolerability of ABT-494, a Novel Selective JAK 1 Inhibitor, in Healthy Volunteers and Subjects with Rheumatoid Arthritis. Clin Pharmacokinet. 2016 Dec;55(12):1547-1558. doi: 10.1007/s40262-016-0419-y.'}, {'pmid': '29076110', 'type': 'DERIVED', 'citation': 'Klunder B, Mohamed MF, Othman AA. Population Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects with Rheumatoid Arthritis: Analyses of Phase I and II Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):977-988. doi: 10.1007/s40262-017-0605-6.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and multiple dose study in healthy volunteers.', 'detailedDescription': 'To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy Volunteers:\n\n* Male and female subjects 18 to 55 years of age, inclusive.\n* Subject is judged to be in good general health.\n\nRheumatoid Arthritis Patients:\n\n* Male and female patients 18 to 75 years of age, inclusive.\n* Subject has a diagnosis of rheumatoid arthritis for at least six months.\n* Subject has been on methotrexate therapy for at least three months and on a stable dose for at least four weeks.\n\nExclusion Criteria:\n\n* History or evidence of active or latent tuberculosis.\n* History or significant allergic reaction to any drug.\n* Use of known strong CYP3A and CYP2D6 inhibitors and CYP3A inducers within 21 days or within 5 half-lives of the respective medication, whichever is longer.\n* Current or expected need for oral intake of at least 10 mg prednisone per day or equivalent corticosteroid therapy.\n* History of acute inflammatory joint disease of different origin other than rheumatoid arthritis (rheumatoid arthritis patients).'}, 'identificationModule': {'nctId': 'NCT01741493', 'briefTitle': 'A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494', 'orgStudyIdInfo': {'id': 'M13-845'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers (ABT-494)', 'description': 'Multiple dosing of ABT-494 in healthy volunteers', 'interventionNames': ['Drug: ABT-494']}, {'type': 'EXPERIMENTAL', 'label': 'Rheumatoid Arthritis Patients', 'description': 'Multiple dosing of ABT-494 in patients with rheumatoid arthritis', 'interventionNames': ['Drug: ABT-494']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No treatment', 'description': 'Placebo administration in healthy volunteers and patients with rheumatoid arthritis', 'interventionNames': ['Drug: Placebo']}, {'type': 'OTHER', 'label': 'Healthy Volunteers (tofa)', 'description': 'Multiple dosing of tofacitinib in healthy volunteers', 'interventionNames': ['Drug: Tofacitinib']}], 'interventions': [{'name': 'ABT-494', 'type': 'DRUG', 'description': 'Oral administration of ABT-494 capsules', 'armGroupLabels': ['Healthy Volunteers (ABT-494)', 'Rheumatoid Arthritis Patients']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration of placebo capsules', 'armGroupLabels': ['No treatment']}, {'name': 'Tofacitinib', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Healthy Volunteers (tofa)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 95817', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '45255', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 95816', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 95815', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 92153', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84058', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 97177', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}], 'overallOfficials': [{'name': 'Steven Jungerwirth, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}