A PHASE 1, OPEN-LABEL, MULTIPLE DOSE STUDY TO INVESTIGATE THE IMPACT OF PF 08653944 ON GASTRIC EMPTYING IN ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax)
研究概览
简要总结
This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity.
Participants will receive the study medicine for a short period, and doctors will measure how the medicine moves through the stomach and monitor safety. The goal is to better understand how this medicine works in the body and to check for any side effects.
The information from this study may help researchers plan future studies of this medicine.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG.
- •Body mass index (BMI) 27-45 kg/m² and body weight >50 kg (110 lb).
- •Participants with overweight or obesity
排除标准
- •History or presence of clinically significant medical conditions, including but not limited to:
- •-Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders.
- •Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL.
- •Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.
研究组 & 干预措施
Period 1
Participants will receive a single oral dose of acetaminophen.
干预措施: Acetaminophen (Drug)
Period 2
Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.
干预措施: Acetaminophen (Drug)
Period 2
Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.
干预措施: PF-08653944 (Drug)
Period 3
Participants will receive SC dose of PF-0865394.
干预措施: PF-08653944 (Drug)
Period 4
Participants will receive SC dose of PF-0865394.
干预措施: PF-08653944 (Drug)
Period 5
Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.
干预措施: Acetaminophen (Drug)
Period 5
Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.
干预措施: PF-08653944 (Drug)
Period 6
Participants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen.
干预措施: PF-08653944 (Drug)
Period 6
Participants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax)
时间窗: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
Acetaminophen PK parameters: Area under the plasma concentration (AUC)
时间窗: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.
Acetaminophen PK parameters: Time to Maximum concentration (Tmax)
时间窗: Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
次要结局
- Number of participants with Treatment Emergent Adverse Events (TEAEs)(First dose through study completion, approximately 11 Weeks post last dose.)