NCT06568731已完成1 期
A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) 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
- about the safety and tolerability of danuglipron
The total number of weeks of the study is about 15 (about 4 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •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
研究组 & 干预措施
Single Arm
Experimental
Participants will receive multiple doses of danuglipron
干预措施: Danuglipron (Drug)
结局指标
主要结局
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 maximum observed concentration (Cmax) 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
次要结局
- Number of participants reporting Treatment Emergent Adverse Events (TEAEs)(From baseline up to 28-35 days post last dose taken)
- 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 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 clinically significant changes ECG abnormalities(From baseline up to 28-35 days post last dose taken)
研究者
研究点 (1)
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