NCT07428525已完成1 期
A Phase 1, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics of AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
Amgen5 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年3月14日最近更新:
干预措施
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
- 5
- 主要终点
- Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133
研究概览
简要总结
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal 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
- •Adults 18 to 75 years of age, male or female.
- •Body mass index ≥ 22 kg/m^2 at screening.
- •For participants with normal hepatic function:
- •In good health with no clinically significant findings from medical history, physical exam, electrocardiogram (ECG), vital signs, or laboratory tests.
- •Systolic blood pressure (BP) 90-150 mmHg and diastolic BP 50-100 mmHg; pulse 40-110 bpm.
- •Stable body weight (< 5 kg change) and no recent dietary modifications within 3 months.
- •For participants with hepatic impairment:
- •Documented Child-Pugh Class A (mild), B (moderate), or C (severe) hepatic impairment.
- •Clinically stable chronic liver disease (e.g., cirrhosis, hepatitis B, alcoholic liver disease, or stable hepatitis C).
- •Systolic BP ≤ 170 mmHg and diastolic BP ≤ 100 mmHg.
- •Willing to use reliable contraception (if of childbearing potential) or practice abstinence through 16 weeks after dosing.
排除标准
- •Any unstable medical condition (e.g., recent hospitalization or major surgery).
- •History of acute or chronic pancreatitis within 1 year or lipase/amylase > 2× ULN at screening.
- •Endocrine disorder that can cause obesity (e.g., Cushing's syndrome).
- •Significant cardiac conditions (e.g., clinically meaningful arrhythmias, 2nd/3rd-degree AV block, QT Interval Corrected Using Fridericia's Formula (QTcF) >450 msec men / >470 msec women for normal hepatic group; > 490 msec men / > 500 msec women for hepatic impairment).
- •Estimated glomerular filtration rate < 60 mL/min/1.73 m^2 (normal/mild) or < 50 mL/min/1.73 m^2 (moderate/severe impairment).
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type
- •Uncontrolled thyroid disease or clinically significant gastroparesis.
- •Prior bariatric surgery within 6 months.
- •Poor venous access.
- •Positive Human Immunodeficiency Virus (HIV) test.
- •Hypersensitivity to AMG 133 or its components.
- •Current use of GLP-1 or GIP receptor agents within 3 months.
- •Pregnancy or lactation, or unwillingness to follow contraception requirements.
- •History of substance or alcohol abuse within 1 year or current alcohol intake > 21 units/week (men) or > 14 units/week (women).
- •Positive test for hepatitis B surface antigen or active hepatitis C (with unstable disease).
- •Diabetes mellitus not meeting glycemic cutoffs (hemoglobin A1C ≥ 6.5 % for normal hepatic group or > 11 % for hepatic impairment group).
- •Active malignancy (within 18 months for hepatic impairment group; within 5 years for normal hepatic group).
- •Hepatic encephalopathy Grade ≥ 3 (uncontrolled) or severe uncontrolled ascites.
- •Organ transplant recipients or those on immunosuppressants.
- •Participation in another clinical trial within 30 days or 5 drug half-lives (whichever is longer).
研究组 & 干预措施
Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment)
Experimental
Participants with severe hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
干预措施: AMG 133 (Drug)
Group 1, AMG 133: Normal Hepatic Function (No Impairment)
Experimental
Participants with normal hepatic function will receive a single dose of AMG 133 SC on Day 1.
干预措施: AMG 133 (Drug)
Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment)
Experimental
Participants with mild hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
干预措施: AMG 133 (Drug)
Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment)
Experimental
Participants with moderate hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
干预措施: AMG 133 (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133
时间窗: Up to Day 120
AUC from Time Zero to Infinity (AUCinf) of AMG 133
时间窗: Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of AMG 133
时间窗: Up to Day 120
次要结局
- Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)(Up to Day 120)
- Number of Participants Who Experience Serious Adverse Events (SAEs)(Up to Day 120)
- Number of Participants Who Develop Anti-AMG 133 Antibodies(Up to Day 120)
研究者
研究点 (5)
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