A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Digoxin in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Digoxin in Plasma
研究概览
简要总结
Researchers have designed a new study medicine called enlicitide decanoate 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.
The purpose of this study is to learn the effect of this new study medicine enlicitide on digoxin (medicine used in heart disease) over time (a pharmacokinetic or PK study). Researchers will compare what happens to digoxin in the body over time when it is given with this new study medicine enlicitide in healthy adult participants.
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 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 in good health before randomization
- •Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant psychiatric, immunological, gastrointestinal, cardiovascular abnormalities or diseases.
- •Has a history of cancer.
- •Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
研究组 & 干预措施
Sequence 2: 0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate-->0.25mg Digoxin
Participants will receive 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 1 and will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 2.
干预措施: Enlicitide (Drug)
Sequence 1: 0.25mg Digoxin-->0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate
Participants will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 1 and 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 2.
干预措施: Enlicitide (Drug)
Sequence 1: 0.25mg Digoxin-->0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate
Participants will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 1 and 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 2.
干预措施: Digoxin (Drug)
Sequence 2: 0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate-->0.25mg Digoxin
Participants will receive 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 1 and will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 2.
干预措施: Digoxin (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Digoxin in Plasma
时间窗: At designated timepoints (up to 5 days)
AUC0-inf is the area under the plasma concentration versus time curve (AUC) for digoxin, from time zero (pre-dose) to extrapolated infinite time.
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) for Digoxin in Plasma(At designated timepoints (up to 5 days))
- Cmax (Maximum Concentration) for Digoxin in Plasma(At designated timepoints (up to 5 days))
- Tmax (Time to Maximum Concentration) for Digoxin in Plasma(At designated timepoints (up to 5 days))
- Terminal half life (T½) for Digoxin in Plasma(At designated timepoints (up to 5 days))
- Apparent Clearance (CL/F) for Digoxin in Plasma(At designated timepoints (up to 5 days))
- Apparent Volume of Distribution During Terminal Phase (Vz/F) for Digoxin in Plasma(At designated timepoints (up to 5 days))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs):(Up to ~ 28 days.)
- Number of Participants With Clinical Laboratory Abnormalities(Up to ~ 28 days)
- Standard and Orthostatic Vital Signs(Up to ~ 28 days)
- 12-lead Electrocardiogram (ECGs)(Up to ~ 28days)