A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Tofacitinib; Upadacitinib

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).