A Clinical Study to Evaluate the Effect of MK-0616 on the Pharmacokinetics of Levothyroxine in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)
研究概览
简要总结
Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Enlicitide decanoate was designed to lower the amount of cholesterol in a person's blood.
Researchers want to learn about levothyroxine when taken at the same time with enlicitide decanoate. They want to:
- Measure a person's blood to find out if the amount of levothyroxine in the blood is the same when levothyroxine is taken alone or with enlicitide decanoate
- Learn about the safety of levothyroxine when taken alone or with enlicitide decanoate and if people tolerate it
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
- 19 Years 至 50 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:
- •Medically healthy with no clinically significant medical history
- •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:
- •History of cardiovascular disease or diabetes mellitus
- •History of cancer
研究组 & 干预措施
Levothyroxine
Participants will receive a single oral dose of levothyroxine.
干预措施: Levothyroxine (Drug)
Levothyroxine Plus Enlicitide Decanoate
Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time.
干预措施: Levothyroxine (Drug)
Levothyroxine Plus Enlicitide Decanoate
Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time.
干预措施: Enlicitide Decanoate (Drug)
结局指标
主要结局
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)
时间窗: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the AUC0-48hr of Levothyroxine (T4).
Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4)
时间窗: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Cmax of Levothyroxine (T4).
Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4)
时间窗: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Tmax of Levothyroxine (T4).
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3)
时间窗: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3).
Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3)
时间窗: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Cmax of triiodothyronine (T3).
Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3)
时间窗: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Tmax of triiodothyronine (T3).
次要结局
- Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)(Up to approximately 7 weeks)
- Number of Participants Who Discontinue Study Due to a TEAE(Up to approximately 7 weeks)