An Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline
研究概览
简要总结
The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, 18 years of age or older with active rheumatoid arthritis; Or male and female healthy volunteers 18 years of age and older
排除标准
- •Pregnant or lactating women
- •Clinically significant systemic disease (other than RA for RA arm)
- •Use of lipid-regulating agents
研究组 & 干预措施
CP-690,550 (tasocitinib) 10 mg twice daily (BID)
干预措施: CP-690,550 (tasocitinib) (Drug)
结局指标
主要结局
High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline
时间窗: Baseline
Blood level of HDL-C was measured following a 12-hours fasting.
High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6
时间窗: Week 6
Blood level of HDL-C was measured following a 12-hours fasting.
Cholesterol Ester Production Rate at Baseline
时间窗: Baseline
Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Cholesterol Ester Production Rate at Week 6
时间窗: Week 6
Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
次要结局
- Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration(Baseline, Week 6)
- Cholesterol Ester Fractional Catabolic Rate(Baseline, Week 6)
- Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate(Baseline, Week 6)
- Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate(Baseline, Week 6)
- High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate(Baseline, Week 6)
- High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate(Baseline, Week 6)
- Cholesterol Efflux Rate(Baseline, Week 6)