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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
67
Oral administration of ABT-494 capsules
Oral administration of placebo capsules
Oral administration
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
Number and percentage of participants with Adverse Events
Time frame: From first dose up to 28 days after the last dose of study drug
Vital Signs
Blood pressure, pulse rate and body temperature
Time frame: From first dose up to 28 days after the last dose of study drug
Clinical Lab testing
Hematology, Chemistry, and Urinalysis
Time frame: 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
Time frame: 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
Time frame: Prior to first dose up to 72 hours after the last dose of ABT-494
Pharmacokinetics of Methotrexate
Cmax, Tmax, AUC, elimination rate constant and half-life
Time frame: Prior to first dose up to 48 hours after the last dose of methotrexate
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Site Reference ID/Investigator# 97177
Orem, Utah, United States