Clinical trial NCT01741493: A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Methotrexate
Tolerability
Pharmacokinetics
Safety
Tofacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.

Eligibility criteria: Inclusion Criteria:

Healthy Volunteers:

* 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 evidence of active or latent tuberculosis.
* 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).

Primary outcomes:
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
measure: Clinical Lab testing
timeFrame: From date of first dose up to 28 days after the last dose of study drug
measure: Electrocardiogram (ECG)
timeFrame: Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose
measure: Pharmacokinetics of ABT-494
timeFrame: Prior to first dose up to 72 hours after the last dose of ABT-494
Secondary outcomes:
measure: Pharmacokinetics of Methotrexate
timeFrame: Prior to first dose up to 48 hours after the last dose of methotrexate
Other outcomes:
Locations:
city: Miami
country: United States
facility: Site Reference ID/Investigator# 95817
state: Florida
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 95816
state: Ohio
city: Duncansville
country: United States
facility: Site Reference ID/Investigator# 95815
state: Pennsylvania
city: Austin
country: United States
facility: Site Reference ID/Investigator# 92153
state: Texas
city: Orem
country: United States
facility: Site Reference ID/Investigator# 97177
state: Utah
Study officials:
affiliation: AbbVie
name: Steven Jungerwirth, MD
role: STUDY_DIRECTOR
References:
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.
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.