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

Launched by ABBVIE (PRIOR SPONSOR, ABBOTT) · Dec 3, 2012

Keywords

ClinConnect Summary

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

Gender

ALL

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).