NCT03513588已完成1 期
A PHASE 1B, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF- 06865571 FOR 2 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)
研究概览
简要总结
2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan
- •liver fat greater than or equal to 6% via MRI
排除标准
- •Chronic liver disease
- •Type 2 diabetes requiring drug treatment
- •Unable to undergo MRI
- •History of heart attack or stroke
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PF-06865571 100 mg
Experimental
干预措施: PF-06865571 (Drug)
PF-06865571 600 mg
Experimental
干预措施: PF-06865571 (Drug)
结局指标
主要结局
Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)
时间窗: Baseline (Day 1), Day 15
MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
次要结局
- Number of Participants With Vital Sign Abnormalities(From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days))
- Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571(Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose)
- Apparent Oral Clearance (CL/F) For PF-06865571(Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days))
- Minimum Plasma Concentration (Cmin) For PF-06865571(Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose)
- Maximum Plasma Concentration (Cmax) For PF-06865571(Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose)
- Number of Participants With Laboratory Test Abnormalities(From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days))
- Number of Participants With Electrocardiogram (ECG) Abnormalities(From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days))
- Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571(Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose)
- Peak-to-Trough Ratio (PTR) For PF-06865571(Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose)
研究者
研究点 (6)
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