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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 5
- 主要终点
- Number and percentage of participants with Adverse Events
研究概览
简要总结
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.
详细描述
To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Healthy Volunteers (ABT-494)
Multiple dosing of ABT-494 in healthy volunteers
干预措施: ABT-494 (Drug)
Rheumatoid Arthritis Patients
Multiple dosing of ABT-494 in patients with rheumatoid arthritis
干预措施: ABT-494 (Drug)
No treatment
Placebo administration in healthy volunteers and patients with rheumatoid arthritis
干预措施: Placebo (Drug)
Healthy Volunteers (tofa)
Multiple dosing of tofacitinib in healthy volunteers
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Number and percentage of participants with Adverse Events
时间窗: From first dose up to 28 days after the last dose of study drug
Vital Signs
时间窗: From first dose up to 28 days after the last dose of study drug
Blood pressure, pulse rate and body temperature
Electrocardiogram (ECG)
时间窗: Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose
ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration
Pharmacokinetics of ABT-494
时间窗: Prior to first dose up to 72 hours after the last dose of ABT-494
Cmax, Tmax, AUC, elimination rate constant and half-life
Clinical Lab testing
时间窗: From date of first dose up to 28 days after the last dose of study drug
Hematology, Chemistry, and Urinalysis
次要结局
- Pharmacokinetics of Methotrexate(Prior to first dose up to 48 hours after the last dose of methotrexate)