NCT06704763已完成1 期
A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron
研究概览
简要总结
The purpose of this study is to determine the effect of quinidine on the levels of orforglipron in the blood stream and how long it takes the body to eliminate it, when administered orally in healthy participants.
The study will last up to approximately 8 weeks including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG)
- •Have a hemoglobin level of:
- •at least 11.4 grams per deciliter (g/dL) for individuals assigned female at birth (AFAB), and
- •at least 12.5 g/dL for individuals assigned male at birth (AMAB)
- •Have a body weight equal to or greater than 45 kilograms (kg), and a body mass index within the range of 18.5 to 35.0 kilogram per square meter (kg/m²) at screening
排除标准
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting risk when taking orforglipron, midazolam, or quinidine; or interfering with the interpretation of data
- •Have a 12 lead electrocardiogram (ECG) abnormality, including known prolongation of QT/QTc interval, significant bradycardia, significant heart blocks or a history of any risk factors for ventricular arrhythmia, heart failure, hypokalemia or hypomagnesemia, or other factors that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have an abnormal blood pressure or pulse rate, deemed to be clinically significant by the investigator
- •Have a history of benign ethnic neutropenia
- •Have a GI disease or disorder, such as relevant esophageal reflux or gall bladder disease, which could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or impacts gastric emptying, for example gastric bypass surgery or pyloric stenosis, except for appendectomy
- •Have a history or presence of pancreatitis, including chronic pancreatitis or idiopathic acute pancreatitis
- •Have known allergies to:
- •quinidine
- •midazolam
- •orforglipron
- •related compounds, or
- •any components of the formulation
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron
时间窗: Baseline to Study Completion (Up to 2 Weeks)
PK: AUC of Orforglipron
PK: Maximum Concentration (Cmax) of Orforglipron
时间窗: Baseline to Study Completion (Up to 2 Weeks)
PK: Cmax of Orforglipron
次要结局
- PK: AUC of Midazolam(Baseline to Study Completion (Up to 2 Weeks))
- PK: Cmax of Midazolam(Baseline to Study Completion (Up to 2 Weeks))
研究者
研究点 (2)
Loading locations...
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