A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-07054894 IN HEALTHY ADULT JAPANESE PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (AE) or serious adverse events (SAE)
研究概览
简要总结
The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.
The study is seeking the following participants:
- Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.
- Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).
- Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy male and female Japanese subjects aged 18 years or older
- •Body Mass Index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (100 lb)
排除标准
- •Evidence or history of clinically significant disease or medical conditions
- •Positive urine drug test or history of alcohol abuse or illicit drug use.
研究组 & 干预措施
PF-07054894
干预措施: PF-07054894 or placebo (Drug)
Placebo
干预措施: PF-07054894 or placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AE) or serious adverse events (SAE)
时间窗: Screening, Baseline through study completion, an average of 11 weeks
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs.
Time to Maximum Plasma Concentration (Tmax)
时间窗: Day 1 and 14
Tmax will be observed directly from data
Half-life of PF-07054894
时间窗: Day 14
terminal elimination half-life will be calculated based on the measured data
Number of participants with clinically meaningful change from baseline in laboratory tests results
时间窗: Screening, Baseline, Day 2, 7 and 14
Number of participants with clinically meaningful change from baseline in vital signs
时间窗: Screening, Day 1, 2, 7, 14, and 15
Number of participants with change from baseline in vital signs including supine blood pressure and pulse rate
Maximal plasma concentration (Cmax)
时间窗: Day 1 and 14
The maximum observed plasma concentration (Cmax) will be observed directly from data.
Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters
时间窗: Screening, Day 1, 2, 7, 14 and 15
Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt)
时间窗: Day 1 and 14
AUCτ is summarized by dosing interval and day. Dosing interval is the interval τ between administration of doses of drug.
次要结局
- Apparent Volume of Distribution (Vz/F) as data permits(Day 14)
- Apparent Oral Clearance (CL/F)(Day 14)
- Observed Accumulation Ratio (Rac)(Day 14)
- Observed Accumulation Ratio Based on Cmax (Rac,Cmax)(Day 14)
- Trough plasma concentrations (Ctrough)(Day 14)