NCT04971928已完成1 期
A Phase 1, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics of GSK3228836 in Adults With Hepatic Impairment and Healthy Matched Control Participants (B-Assured)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]
研究概览
简要总结
This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic impairment) and participants with normal hepatic function as healthy control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Body weight >50 Kilogram (kg) and body mass index (BMI) within the range 19 to 40 Kilogram per square meters (kg/m2) (inclusive)
- •Capable of giving signed informed consent.
- •Child-Pugh B cirrhosis (moderate hepatic impairment; Part 1) or Child-Pugh A cirrhosis (mild hepatic impairment; Part 2) or a healthy control participant based on a medical evaluation including medical history, physical examination (PE), laboratory tests.
排除标准
- •Diagnosed or suspected hepatocellular carcinoma.
- •History of malignancy within the past 5 years except for cancers that are cured by surgical resection (e.g., skin cancer).
- •History of vasculitis or presence of symptoms and signs of potential vasculitis or history/presence of other diseases that may be associated with vasculitis condition.
- •Unstable cardiac function or high blood pressure that is not controlled (based on the investigator's discretion).
- •Any other medical condition which, in the judgment of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant.
- •Participants who have taken or are currently taking any therapies not allowed by the protocol.
- •A positive test for human immunodeficiency virus (HIV) antibody.
- •History of sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
研究组 & 干预措施
Participants with Moderate (CP-B) hepatic impairment
Experimental
干预措施: GSK3228836 (Drug)
Participants with Mild (CP-A) hepatic impairment
Experimental
干预措施: GSK3228836 (Drug)
Healthy participants
Experimental
干预措施: GSK3228836 (Drug)
结局指标
主要结局
Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]
时间窗: Up to Day 50 post-dose
Maximum observed concentration (Cmax)
时间窗: Up to Day 50 post-dose
次要结局
- AUC from time zero (pre-dose) to 24 hours [AUC(0-24)](Up to 24 hours post-dose)
- AUC from time zero (pre-dose) to 168 hours [AUC(0-168)](Up to 168 hours post-dose)
- Plasma concentration of GSK3228836 on Day 8(Day 8 post-dose)
- Apparent clearance (CL/F)(Up to Day 50 post-dose)
- Time of occurrence of Cmax (Tmax)(Up to Day 50 post-dose)
- Apparent terminal phase half-life (t1/2)(Up to Day 50 post-dose)
- Apparent terminal phase volume of distribution (Vz/F)(Up to Day 50 post-dose)
研究者
研究点 (1)
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