NCT07429045已完成1 期
A Phase 1, Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AMG 133 in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment
Amgen5 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年3月11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
- 44
- 试验地点
- 5
- 主要终点
- Maximum Observed Concentration (Cmax) of AMG 133
研究概览
简要总结
The primary objective of this trial is to evaluate the pharmacokinetics of a single subcutaneous (SC) dose of AMG 133 in participants with various degrees of renal impairment compared to participants with normal renal 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
- •All Participants in Groups 1 to 5
- •Male or female, of any race, between 18 and 75 years of age, inclusive.
- •a. Females must not be pregnant or lactating.
- •Body mass index > 22.0 kg/m
- •Eligible participants classified based on eGFR at screening and established need for renal replacement therapy as applicable.
- •Participants with Normal Renal Function
- •In good health as determined by no clinically significant findings from medical history, physical examination, vital signs measurements, 12-lead ECGs, and clinical laboratory evaluations.
- •Participants with Renal Impairment
- •Participants with renal impairment may have medical findings consistent with their renal dysfunction.
排除标准
- •All Participants in Groups 1 to 5
- •History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- •History or evidence of endocrine disorder.
- •History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (> 2 x ULN) at screening, or fasting serum triglyceride level of > 500 mg/dL at screening.
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type
- •History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients or to related/similar compounds.
- •Active liver disease or hepatic dysfunction.
- •Clinically significant hyperkalemia.
- •Current use or prior use of any GLP-1R agonist, or GIPR agonist or antagonist within the past 3 months prior to check-in.
- •Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives prior to AMG 133 dosing.
- •Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the investigational product.
- •Participants with Normal Renal Function (Group 1)
- •History of active diabetes or evidence based on hemoglobin A1C of > 6.5% (> 48 mmol/mol).
- •Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- •A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile.
- •Participants with Renal Impairment (Groups 2 to 5)
- •Participants who have a current, functioning organ transplant and/or are on immunosuppressants.
- •Participants on the national transplant list who anticipate receiving an organ transplant within 6 months of check-in.
- •History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.
- •Use of any over-the-counter or prescription medications within 30 days or 5 half-lives before check-in.
- •History of poorly controlled diabetes or evidence based on hemoglobin A1C of > 11% (> 97 mmol/mol).
- •Active malignancy of any type.
- •A change in renal disease status within 30 days of screening.
研究组 & 干预措施
Group 1: Normal renal function
Experimental
Participants with an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min will receive a single dose of AMG 133 as a SC injection.
干预措施: AMG 133 (Drug)
Group 2: Mild renal impairment
Experimental
Participants with an eGFR of 60 to < 90 mL/min will receive a single dose of AMG 133 as a SC injection.
干预措施: AMG 133 (Drug)
Group 3: Moderate renal impairment
Experimental
Participants with an eGFR of 30 to < 60 mL/min will receive a single dose of AMG 133 as a SC injection.
干预措施: AMG 133 (Drug)
Group 4: Severe renal impairment and kidney failure not receiving hemodialysis
Experimental
Participants with an eGFR of < 30 mL/min will receive a single dose of AMG 133 as a SC injection.
干预措施: AMG 133 (Drug)
Group 5: Kidney failure receiving hemodialysis
Experimental
Participants with an eGFR of < 15 mL/min will receive a single dose of AMG 133 as a SC injection.
干预措施: AMG 133 (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of AMG 133
时间窗: Up to Day 120
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
时间窗: Up to Day 120
AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133
时间窗: Up to Day 120
次要结局
- Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)(Day 1 to Day 120)
- Number of Participants who Experienced Serious AEs (SAEs)(Screening to Day 120 (up to 148 days))
- Number of Participants with Positive Anti-AMG 133 Antibody Formation(Up to Day 120)
研究者
研究点 (5)
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