A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Methotrexate Maximum Plasma Concentration
研究概览
简要总结
The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 years old
- •Must be willing to practice 2 adequate methods of contraception for the duration of the study
- •Rheumatoid arthritis present for at least 3 months; functional class I, II, or III as defined by ACR criteria
- •Treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
- •Ability to provide written informed consent
排除标准
- •Women who are pregnant or nursing
- •History of other current inflammatory arthritis
- •History of opportunistic infection
- •History of recurrent infections or current infection 2 weeks prior to start of study
- •Presence of significant, uncontrolled medical problems
- •Treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study
- •Use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, H-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start
- •Receipt of live vaccine within 8 weeks prior to study start
- •Rheumatoid arthritis, functional class IV as defined by ACR criteria
研究组 & 干预措施
LX3305
Daily oral intake of LX3305 for 14 days.
干预措施: LX3305 (Drug)
LX3305
Daily oral intake of LX3305 for 14 days.
干预措施: Methotrexate (Drug)
LX3305 Placebo
Matching placebo dosing with daily oral intake for 14 days.
干预措施: LX3305 Placebo (Drug)
LX3305 Placebo
Matching placebo dosing with daily oral intake for 14 days.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Methotrexate Maximum Plasma Concentration
时间窗: Day 15
Time to Reach Maximum Plasma Concentration of Methotrexate
时间窗: Day 15
Half-life of Methotrexate in Plasma
时间窗: Day 15
Amount of Methotrexate Excreted in the Urine
时间窗: Day 15
7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration
时间窗: Day 15
7-OH-MTX is the primary metabolite of methotrexate.
Time to Reach Maximum Plasma Concentration of 7-OH-MTX
时间窗: Day 15
Amount of 7-OH-MTX Excreted in the Urine
时间窗: Day 15
次要结局
- Maximum Plasma Concentration of LX3305 in the Presence of MTX(Day 15)
- Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX(Day 15)
- Half-life of LX3305 in Plasma in the Presence of MTX(Day 15)
- Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15(Day 15)