A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
NCT ID: NCT01741493
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
67 participants
INTERVENTIONAL
2012-11-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
TRIPLE
Study Groups
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Healthy Volunteers (ABT-494)
Multiple dosing of ABT-494 in healthy volunteers
ABT-494
Oral administration of ABT-494 capsules
Rheumatoid Arthritis Patients
Multiple dosing of ABT-494 in patients with rheumatoid arthritis
ABT-494
Oral administration of ABT-494 capsules
No treatment
Placebo administration in healthy volunteers and patients with rheumatoid arthritis
Placebo
Oral administration of placebo capsules
Healthy Volunteers (tofa)
Multiple dosing of tofacitinib in healthy volunteers
Tofacitinib
Oral administration
Interventions
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ABT-494
Oral administration of ABT-494 capsules
Placebo
Oral administration of placebo capsules
Tofacitinib
Oral administration
Eligibility Criteria
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Inclusion Criteria
* Male and female subjects 18 to 55 years of age, inclusive.
* Subject is judged to be in good general health.
Rheumatoid Arthritis Patients:
* Male and female patients 18 to 75 years of age, inclusive.
* Subject has a diagnosis of rheumatoid arthritis for at least six months.
* Subject has been on methotrexate therapy for at least three months and on a stable dose for at least four weeks.
Exclusion Criteria
* History or significant allergic reaction to any drug.
* 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.
* Current or expected need for oral intake of at least 10 mg prednisone per day or equivalent corticosteroid therapy.
* History of acute inflammatory joint disease of different origin other than rheumatoid arthritis (rheumatoid arthritis patients).
18 Years
75 Years
ALL
Yes
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Jungerwirth, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 95817
Miami, Florida, United States
Site Reference ID/Investigator# 95816
Cincinnati, Ohio, United States
Site Reference ID/Investigator# 95815
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 92153
Austin, Texas, United States
Site Reference ID/Investigator# 97177
Orem, Utah, United States
Countries
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References
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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.
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.
Other Identifiers
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M13-845
Identifier Type: -
Identifier Source: org_study_id