Multiple-Rising Dose Clinical Study to Evaluate the Safety and Pharmacokinetics of MK-0616 in Healthy Participants and in Male and Female Participants Taking Statins
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older 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 in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
- •Has a body mass index (BMI)≥18 and ≤32 kg/m^2
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major (including stroke and chronic seizures) abnormalities or diseases
- •Has a history of cancer
研究组 & 干预措施
Enlicitide Chloride
Participants receive enlicitide chloride titrated orally from Dose 1, Dose 2, or Dose 3 once daily (QD) over the course of a 14-day treatment for each dose based on the safety and tolerability of the previous starting dose. The total treatment duration is up to approximately 6 weeks.
干预措施: Enlicitide Chloride (Biological)
Placebo
Participants receive placebo orally for up to approximately 6 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 56 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to approximately 42 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
次要结局
- Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride(At designated timepoints (up to approximately 24 hours))
- Maximum Plasma Concentration (Cmax) of Enlicitide Chloride(At designated timepoints (up to approximately 1 week))
- Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride(At designated timepoints (up to approximately 1 week))
- Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride(At designated timepoints (up to approximately 1 week))
- Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride(At designated timepoints (up to approximately 1 week))
- Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride(Baseline, Week 1)