A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-08642534 IN ADULTS WITH OBESITY
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events (TEAE)
研究概览
简要总结
This study will look at a study drug called PF-08642534 in people with obesity (have too much body weight) to see: if participants can take different amounts (doses) of the study drug in a safe way and how adults with obesity tolerate it, and how the body handles the study drug (for example, how the study drug is absorbed and removed from the body).
People who want to join the study will first go through a screening period of up to 4 weeks. Doctors will check if each person meets the study conditions, including age, body weight, and general health. People with certain medical conditions will not be able to take part in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) ≥30.0 and ≤40.0 kg/m², and with stable body weight prior to screening.
- •Participants are generally otherwise healthy but may have mild chronic conditions (eg, dyslipidemia or hypertension)
排除标准
- •- Individuals with diabetes, significant cardiovascular, hepatic, renal, gastrointestinal, or psychiatric disorders, or conditions that may affect drug absorption or metabolism, are not eligible to participate.
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAE)
时间窗: Baseline up to 8 weeks after last dose
次要结局
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-08642534(0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose)
- Maximum Observed Plasma Concentration (Cmax) of PF-08642534(0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose)
