A Phase 1, 4-Part, Open-Label, Randomized Study With A 5-Period, 4 Sequence, Crossover Design to Compare the Single Dose Pharmacokinetics Between Immediate and Modified Release Formulations of Danuglipron Administered Orally to Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state
研究概览
简要总结
The purpose of the study is to learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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 or older and overtly healthy
- •Body mass Index (BMI) between 16-32 kg/m2; and a total body weight >50 kg (110 lb)
排除标准
- •Evidence or history of clinically significant medical conditions or laboratory abnormality
- •Any condition possibly affecting drug absorption
- •Known intolerance/hypersensitivity to a GLP-1 R agonist
- •Use of prescription drugs, nonprescription drugs, dietary supplements or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of danuglipron in each part of the study.
研究组 & 干预措施
Part A
Participants will receive a single oral dose of danuglipron on Day 1 of each period
干预措施: Danuglipron (Drug)
Part B
Participants will receive a single oral dose of danuglipron on Day 1 of each period
干预措施: Danuglipron (Drug)
Part C
Participants will receive a single oral dose of danuglipron on Day 1 of each period
干预措施: Danuglipron (Drug)
Part D
Participants will receive a single oral dose of danuglipron on Day 1 of each period
干预措施: Danuglipron (Drug)
结局指标
主要结局
Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state
时间窗: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state
时间窗: Predose to 48 hours post danuglipron administration
Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state
时间窗: Predose to 48 hours post danuglipron administration
Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state
时间窗: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state
时间窗: Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state
时间窗: Predose to 48 hours post danuglipron administration
次要结局
- All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities(From baseline up to 28-35 days post last dose taken)
- All Parts: Number of Participants reporting Treatment Emergent Adverse Events(From baseline up to 28-35 days post last dose taken)
- All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities(From baseline up to 28-35 days post last dose taken)
- All Parts: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fed state(Predose to 48 hours post danuglipron administration)
- All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities(From baseline up to 28-35 days post last dose taken)
- All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state(Predose to 48 hours post danuglipron administration)
- All Parts: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fed state(Predose to 48 hours post danuglipron administration)