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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.
To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers (ABT-494) | Experimental | Multiple dosing of ABT-494 in healthy volunteers |
|
| Rheumatoid Arthritis Patients | Experimental | Multiple dosing of ABT-494 in patients with rheumatoid arthritis |
|
| No treatment | Placebo Comparator | Placebo administration in healthy volunteers and patients with rheumatoid arthritis |
|
| Healthy Volunteers (tofa) | Other | Multiple dosing of tofacitinib in healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-494 | Drug | Oral administration of ABT-494 capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants with Adverse Events | From first dose up to 28 days after the last dose of study drug | |
| Vital Signs | Blood pressure, pulse rate and body temperature | From first dose up to 28 days after the last dose of study drug |
| Clinical Lab testing | Hematology, Chemistry, and Urinalysis | From date of first dose up to 28 days after the last dose of study drug |
| Electrocardiogram (ECG) | ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration | Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose |
| Pharmacokinetics of ABT-494 | Cmax, Tmax, AUC, elimination rate constant and half-life | Prior to first dose up to 72 hours after the last dose of ABT-494 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Methotrexate | Cmax, Tmax, AUC, elimination rate constant and half-life | Prior to first dose up to 48 hours after the last dose of methotrexate |
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Inclusion Criteria:
Healthy Volunteers:
Rheumatoid Arthritis Patients:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Jungerwirth, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 95817 | Miami | Florida | 33136 | United States | ||
| Site Reference ID/Investigator# 95816 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27272171 | Result | 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. | |
| 29076110 | Derived |
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| Placebo | Drug | Oral administration of placebo capsules |
|
| Tofacitinib | Drug | Oral administration |
|
| Cincinnati |
| Ohio |
| 45255 |
| United States |
| Site Reference ID/Investigator# 95815 | Duncansville | Pennsylvania | 16635 | United States |
| Site Reference ID/Investigator# 92153 | Austin | Texas | 78744 | United States |
| Site Reference ID/Investigator# 97177 | Orem | Utah | 84058 | United States |
| 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. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
| C479163 | tofacitinib |
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