NCT04823702已完成1 期
A Phase I, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Aldafermin in Subjects With Impaired Hepatic Function
NGM Biopharmaceuticals, Inc6 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Pharmacokinetics of a single dose of aldafermin
研究概览
简要总结
This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, 18 - 75 years of age, inclusive
- •Able to comprehend and willing to sign an informed consent form (ICF)
- •Willing and able to comply with all study requirements
- •BMI 18 - 40 kg/m2, inclusive at Screening
- •Stable medication regimen - no medication initiation or dose change within 7 days or 5 half-lives (whichever is longer) prior to dosing of the study medication.
- •Non-pregnant, non-lactating females. Female subjects of childbearing potential and male subjects with a female sexual partner of childbearing potential must agree to consistent and adequate birth control. One of the following forms of contraception is required:
- •Hormone containing contraceptive
- •Intrauterine device with a failure rate < 1% per year
- •Cervical cap or diaphragm with spermicidal agent
- •Tubal sterilization
- •Vasectomy in male partner
- •Sexual abstinence
- •Negative test for drugs of abuse at Screening unless they are currently prescribed
- •Negative human immunodeficiency virus (HIV) antibody screen at Screening
排除标准
- •Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact hepatic function
- •History of or recent (< 6 weeks) treatment for a chronic condition with a medication that is known to have hepatotoxic potential.
- •Any significant physical injury or surgical procedure within 6 weeks of Screening
- •Uncontrolled diabetes (hemoglobin A1c [HbA1c] > 9.5%)
- •Uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg on ≥ 3 medications of different classes for blood pressure control)
- •Have received any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to study dosing
- •Subjects should not have donated blood within 60 days of study entry or plasma within 7 days of study entry. Subjects must also refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study medication.
- •Positive urine drug screen at Screening that is not otherwise explained by a permitted concomitant medication
- •History of alcoholism in the 6 months prior to Screening
- •Inadequate peripheral venous access
结局指标
主要结局
Pharmacokinetics of a single dose of aldafermin
时间窗: 4 days
Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity) of aldafermin (Day 1 through Day 4)
Pharmacokinetics (PK) of a single dose aldafermin
时间窗: 4 days
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
次要结局
- Type and frequency of adverse events (Day 1 through Day 11)(11 days)
研究者
研究点 (6)
Loading locations...
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