NCT05435170已完成1 期
A Phase I, Randomized, Open-label, Single Dose, 2 Period, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Linerixibat Tablets in Healthy Adult Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
研究概览
简要总结
This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label study
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of cholecystectomy.
- •Current symptomatic cholelithiasis or inflammatory gall bladder disease.
- •Significant history of or current disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- •Current clinically significant diarrhea.
- •History of gastrointestinal surgery with ileal resection or ileal bypass at any time.
- •Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- •Administration of any other Ileal Bile Acid Transport (IBAT) inhibitor (including linerixibat) in the 3 months prior to screening.
- •Past or intended use of over the counter or prescription medication, including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless approved by the Investigator in conjunction with GSK Medical Monitor.
- •Current enrollment in a clinical trial or recent participation in a clinical trial and has received an investigational product within the following time period prior to study drug administration: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
- •Exposure to more than 4 new chemical entities within 12 months before the first dose in the current study.
- •Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5x upper limit of normal (ULN).
- •Bilirubin >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody test or hepatitis C Ribonucleic acid (RNA) test at screening or within 3 months prior to first dose of study intervention.
- •Positive human immunodeficiency virus (HIV) antibody test
- •Fridericia's QT correction formula (QTcF) >450 msec on ECG performed at screening.
- •Regular use of known drugs of abuse or history of drug abuse or dependence within 6 months of the study.
- •Regular alcohol consumption within 6 months prior to signing the informed consent.
- •Regular use of tobacco- or nicotine-containing products in the 3 months prior to screening.
研究组 & 干预措施
Treatment sequence AB
Experimental
Participants will receive linerixibat in fed state (Treatment A) in period 1 followed by linerixibat in fasted state (Treatment B) in period 2. The washout period will be of at least 7 days.
干预措施: linerixibat (Drug)
Treatment sequence BA
Experimental
Participants will receive linerixibat in fasted state (Treatment B) in period 1 followed by linerixibat in fed state (Treatment A) in period 2. The washout period will be of at least 7 days.
干预措施: linerixibat (Drug)
结局指标
主要结局
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
时间窗: Up to 36 hours post dose
Maximum observed plasma concentration (Cmax) of linerixibat
时间窗: Up to 36 hours post dose
次要结局
- Apparent terminal phase half-life (t1/2) of linerixibat(Up to 36 hours post dose)
- Apparent terminal phase volume of distribution (Vz/F) of linerixibat(Up to 36 hours post dose)
- Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)](Up to 24 hours post dose)
- Apparent clearance (CL/F) of linerixibat(Up to 36 hours post dose)
- Incidence of adverse events (AEs) and of serious adverse events (SAEs)(Up to day 52)
- Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to infinite time [AUC (0-∞)](Up to 36 hours post dose)
- Time of occurrence of Cmax (Tmax) of linerixibat(Up to 36 hours post dose)
- Serum C4 area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)](Up to 24 hours post dose)
- Delay in achieving Tmax (Tlag) of linerixibat(Up to 36 hours post dose)
- Serum C4 area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)](Up to 36 hours post dose)
研究者
研究点 (1)
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