A Two-Part Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Multiple Dose Pharmacokinetics of Danuglipron Following Oral Administration and The Effects of Steady-State Danuglipron on the Pharmacokinetics of Single Oral Dose of Atorvastatin and Rosuvastatin in Otherwise Healthy Adult Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Steady-state maximum observed concentration (Cmax) for danuglipron
研究概览
简要总结
The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:
- how the study medicine, danuglipron, is taken up into the blood
- if the study medicine, danuglipron, changes how the body processes other study medicines (Atorvastatin and Rosuvastatin)
- about the safety and tolerability of danuglipron
The study will take place in 4 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2, 21 weeks (about 5 months) for Cohort 3 and 20 weeks (about 5 months) for Cohort 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to < 65 years of age
- •Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)
排除标准
- •Evidence or history of any clinically significant medical conditions or laboratory abnormality
- •Any condition possibly affecting drug absorption
- •Known intolerance/hypersensitivity to a GLP-1R agonist and/or known hypersensitivity or contraindication to atorvastatin (Cohort 1 and 3 participants) or rosuvastatin (Cohort 2 and 4 participants)
研究组 & 干预措施
Cohort 1
Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
干预措施: Danuglipron (Drug)
Cohort 1
Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
干预措施: Atorvastatin (Drug)
Cohort 2
Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
干预措施: Danuglipron (Drug)
Cohort 2
Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
干预措施: Rosuvastatin (Drug)
Cohort 3
Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
干预措施: Danuglipron (Drug)
Cohort 3
Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
干预措施: Atorvastatin (Drug)
Cohort 4
Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
干预措施: Danuglipron (Drug)
Cohort 4
Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Steady-state maximum observed concentration (Cmax) for danuglipron
时间窗: Predose to 24 hours post danuglipron administration
Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin
时间窗: Predose to 72 hours post atorvastatin administration
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for atorvastatin (only if AUCinf is not reportable)
时间窗: Predose to 72 hours post atorvastatin administration
Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin
时间窗: Predose to 96 hours post rosuvastatin administration
Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron
时间窗: Predose to 24 hours post danuglipron administration
Steady-state time to reach maximum observed concentration (Tmax) for danuglipron
时间窗: Predose to 24 hours post danuglipron administration
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable)
时间窗: Predose to 96 hours post rosuvastatin administration
次要结局
- Number of participants reporting clinically significant clinical laboratory abnormalities(From baseline up to 28-35 days post last dose taken)
- Number of participants reporting clinically significant changes ECG abnormalities(From baseline up to 28-35 days post last dose taken)
- Number of participants reporting clinically significant vital sign abnormalities(From baseline up to 28-35 days post last dose taken)
- Change from baseline in body weight(From baseline up to 28-35 days post last dose taken)
- Number of participants reporting Treatment Emergent Adverse Events (TEAEs)(From baseline up to 28-35 days post last dose taken)