A Phase 1, Open-label, Single-arm Study to Investigate the Effect of Retatrutide on Metoprolol Pharmacokinetics in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under Concentration From Time Zero to Infinity (AUC[0-∞]) of Metoprolol
研究概览
简要总结
The purpose of this study J1I-MC-GZQE is to measure the effect of retatrutide on the pharmacokinetics (PK) of metoprolol in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 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 vital signs
- •Have a body mass index (BMI) within the range 22.0 to 35.0 kilogram per square meter (kg/m2) (inclusive) at screening
排除标准
- •Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimole/mole (mmol/mol)
- •Have a mean supine screening pulse rate of less than 45 or greater than 100 beats per minute (bpm) from 2 assessments. If a repeat measurement (mean of 2 assessments) shows values within the range of 45 to 100 bpm, the participant may be included in the trial
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
- •Had any of the following cardiovascular conditions prior to screening: acute myocardial infarction, cerebrovascular accident, unstable angina, or hospitalization due to congestive heart failure
研究组 & 干预措施
Retatrutide
In period 1, participants will be administered a singe oral dose of metoprolol followed by a 1-week washout before retatrutide subcutaneous (SC) injection is given in period 2, followed by a second dose of metoprolol.
干预措施: Retatrutide (Drug)
Retatrutide
In period 1, participants will be administered a singe oral dose of metoprolol followed by a 1-week washout before retatrutide subcutaneous (SC) injection is given in period 2, followed by a second dose of metoprolol.
干预措施: Metoprolol (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under Concentration From Time Zero to Infinity (AUC[0-∞]) of Metoprolol
时间窗: Day 1 to Day 3
PK: AUC (0-∞) of Metoprolol
Pharmacokinetics (PK): AUC (0-∞) of Metoprolol with Retatrutide
时间窗: Day 9 to Day 11
PK: AUC (0-∞) of Metoprolol with Retatrutide
PK: Maximum Concentration (Cmax) of Metoprolol
时间窗: Day 1 to Day 3
PK: Cmax of Metoprolol
PK: Cmax of Metoprolol with Retatrutide
时间窗: Day 9 to Day 11
PK: Cmax of Metoprolol with Retatrutide
次要结局
- Number of Participants with an Incidence of Treatment Emergent Adverse Events TEAEs (TEAEs)(Baseline to Day 44)