A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Lithium in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma
研究概览
简要总结
Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward. Lithium (also called lithium carbonate) is a medicine used in bipolar disorder.
Researchers want to learn about lithium when taken at the same time with enlicitide.
They want to:
- Measure a person's blood to find out if the amount of lithium in the blood is the same when lithium is taken alone or with enlicitide
- Learn about the safety of lithium when taken alone or with enlicitide and if people tolerate it
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is medically healthy with no clinically significant medical history
- •Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history or presence of clinically significant medical or psychiatric condition or disease
- •Has a history of cancer
研究组 & 干预措施
Lithium Carbonate
On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered.
干预措施: lithium carbonate (Drug)
Enlicitide with Lithium Carbonate
On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide.
干预措施: lithium carbonate (Drug)
Enlicitide with Lithium Carbonate
On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide.
干预措施: enlicitide (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma
时间窗: At designated timepoints (up to approximately 5 days post dose)
Blood samples will be collected to determine the AUC0-inf of lithium in plasma.
Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma
时间窗: At designated timepoints (up to approximately 5 days post dose)
Blood samples will be collected to determine the AUC0-last of lithium in plasma.
Cmax (Maximum Concentration) for Lithium in Plasma
时间窗: At designated timepoints (up to approximately 5 days post dose)
Blood samples will be collected determine the Cmax of lithium in plasma.
次要结局
- Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)(Up to approximately 3 weeks)
- Number of Participants Who Discontinue Study Due to a TEAE(Up to approximately 3 weeks)