Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])
研究概览
简要总结
The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
- •Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
- •Are agreeable to receiving study treatment by injections under the skin
排除标准
- •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 gastrointestinal (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
- •Have a prior history of malignant disease(s) in the past 5 years prior to screening
- •Smoke more than the equivalent of 10 cigarettes per day
- •Is a known user of drugs of abuse
研究组 & 干预措施
Tirzepatide - Upper Arm
Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.
干预措施: Tirzepatide (Drug)
Tirzepatide - Thigh
Participants received 5mg Tirzepatide by subcutaneous injection on thigh.
干预措施: Tirzepatide (Drug)
Tirzepatide - Abdomen
Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])
时间窗: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC\[0-∞\]) was evaluated.
PK: Maximum Concentration (Cmax) of Tirzepatide
时间窗: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated.
次要结局
未报告次要终点