A Single Dose Pharmacokinetic Study of Tirzepatide in Subjects With Varying Degrees of Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide
研究概览
简要总结
The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants. The study will last about two months and will include five visits to the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Participants:
- •Women of childbearing potential are excluded from the study.
- •Women not of childbearing potential may participate and include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal
- •Are between the body mass index (BMI) of 19.0 and 40.0 kilograms per meter squared (kg/m²), inclusive, at screening
- •Healthy Participants:
- •Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function
- •Participants with Impaired Liver Function:
- •Males or females with chronic mild, moderate and severe liver impairment, assessed by Child-Pugh scoring
- •Have type 2 diabetes mellitus (T2DM) controlled with diet or exercise alone or on stable doses of metformin for at least 8 weeks
- •Have a hemoglobin A1c (HbA1c) ≥6.0% and ≤11.0% at screening
排除标准
- •All Participants:
- •Have known allergies to tirzepatide or related compounds
- •Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
- •Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
- •Participants with Impaired Liver Function:
- •Have hemoglobin <8.5 grams per deciliter (g/dL)
- •Have kidney function that is significantly impaired at screening
- •Have taken any glucose-lowering medications other than metformin, including insulin, in the past 3 months before screening
- •Have brain function impaired significantly due to liver condition
研究组 & 干预措施
Normal Hepatic Function
Participants with normal hepatic function received single subcutaneous dose of 5 milligrams (mg) tirzepatide.
干预措施: Tirzepatide (Drug)
Mild Hepatic Impairment
Participants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.
干预措施: Tirzepatide (Drug)
Moderate Hepatic Impairment
Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.
干预措施: Tirzepatide (Drug)
Severe Hepatic Impairment
Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide
时间窗: Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC\[0-∞\]) of Tirzepatide.
PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
时间窗: Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose
PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide.
次要结局
未报告次要终点