NCT07455240进行中（未招募）1 期
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of PF-07328948 Following Multiple Oral Doses in Healthy Chinese Adult Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to learn about:
- How PF-07328948 is changed and removed from the body after taking
- Safety of PF-07328948
- The extent to which undesirable effects can be tolerated after taking PF-07328948 for the possible treatment of heart failure
This study is seeking participants who:
- Are healthy Chinese adults who are aged 18 years old and older
- Have body mass index from 18.5 to under 28 kilograms/meter square
- Have a total body weight over 50 kilograms (110 pounds)
- Do not have a history of blood clots blocking an artery or vein
All participants in this study will receive oral daily PF-07328948 at the study clinic for 7 consecutive days.
The experiences of the participants receiving the study medicine will be looked at. This will help to see if the study medicine is safe.
Participants will take part in this study for around 10 weeks. During this time, participants will have 1 study visit at the study clinical and 1 contact over the phone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Females of non-childbearing potential and males, aged 18 years or older at the time of screening, who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECG.
- •BMI of ≥ 18.5 and < 28.0 kg/m2; and a total body weight >50 kg (110 lb).
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HBV-DNA, HCVAb, HCV-RNA, or syphilis.
- •Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- •Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •History of DVT, pulmonary embolism, or arterial thrombosis.
研究组 & 干预措施
Arm 1
Experimental
Participants will receive oral daily PF-07328948 tablet for 7 consecutive days.
干预措施: PF-07328948 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 1, 7
Area under the plasma concentration (AUC)
时间窗: Day 1, 7
次要结局
- Number of participants with treatment emergent adverse events(First dose through study completion, an average of 10 weeks)
研究者
研究点 (1)
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