NCT00986895已完成1 期
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- The rate of adverse event
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of GT4P administered orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic impairment with cirrhosis (Child-Pugh scores of A, B, or C) and to a gender matched and similar age control group with normal hepatic function.
详细描述
Study acquired from Horizon in 2024.
研究设计
- 研究类型
- Interventional
- 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
- 否
入选标准
- •Subjects were required to fulfill the following criteria in order to participate in the study:
- •Males or females aged ≥ 18 years of age
- •Able to provide written informed consent before any study-related procedures, and ability, in the opinion of the Investigator, to comply with all the requirements of the study
- •Classification to one of the following:
- •current diagnosis of hepatic impairment with cirrhosis
- •healthy subject
- •Subjects with hepatic impairment with cirrhosis were classifiable to one of the following groups:
- •Child-Pugh score A
- •Child-Pugh score B
- •Child-Pugh score C
- •Subjects with hepatic impairment with cirrhosis who were on a therapeutic regimen of lactulose must have been on a stable dose for ≥ 30 days prior to screening
- •If female, a negative pregnancy test at screening and pre-dose on day 0, or a documented sterilization procedure; a female of child-bearing potential must have been using a medically approved birth control method and must have agreed to use the same method of contraception during the full course of the study (on pre-dose day 0 as well as at screening)
- •Weight within the range of 60-100 kg (at screening and pre-dose on day 0)
- •Willing to stop taking any medication that the Sponsor and the Investigator felt was not appropriate for use during the study, beginning 2 days before dosing and throughout the study
排除标准
- •Subjects who fulfilled any of the following criteria were excluded from the study:
- •Clinically significant history or evidence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), as determined by the Investigator
- •Serum sodium < 120 mEq/L
- •Serum creatinine ≥ 1.5 upper limit of normal
- •Potassium ≤ 3.5 mEq/L
- •Other laboratory values outside the normal range which were determined to be clinically significant by the Investigator
- •Significant illness within the last 14 days
- •Oral temperature > 38.5°C or < 36°C and/or a suspected site of active infection
- •Inflammatory bowel disease or malabsorption defined with steatorrhea
- •Active gastrointestinal bleeding, defined as melena, hematochezia, or hematemesis requiring hospitalization within the last 30 days
- •Use of probenecid, valproate, or corticosteroids within the last 24 hours
- •Use of any medication, other than those approved by the Sponsor and Investigator, in the last 48 hours
- •History of seizures within the last 72 hours
- •Positive drugs of abuse urine test
- •Positive alcohol breath test
- •Donation or loss of blood (500 mL or more) within the last 30 days
- •Donation or loss of plasma within the last 7 days
- •History of acquired immunodeficiency syndrome (AIDS) or determined human immunodeficiency virus (HIV) positive
- •Hepatitis B or C (HBV; HCV) positive (healthy volunteers only)
- •Use of any investigational drug within the last 30 days
- •Known hypersensitivity to sodium phenylbutyrate or similar drugs
- •Emergency hospitalization within the last 90 days
- •Intake of alcohol in the last 7 days
- •Pre-dose (days 0 and 7):
- •Significant illness or emergency hospitalization since the last study visit
- •Oral temperature > 38.5°C or < 36°C and/or a suspected site of active infection
- •Use of probenecid, valproate, or corticosteroids within the last 24 hours
- •Use of any non-approved medication (by the Sponsor/Investigator) within the 48 hours before dosing
- •History of seizures within the last 72 hours
- •Positive drugs of abuse urine test
- •Positive alcohol breath test
- •Donation or loss of blood (500 mL or more) or plasma since the last study visit
- •Use of any investigational drug since the last study visit
- •Intake of alcohol in the last 7 days
结局指标
主要结局
The rate of adverse event
次要结局
未报告次要终点
研究者
研究点 (4)
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