A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07923568 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 11
- 主要终点
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
研究概览
简要总结
The purpose of this study is to understand how the loss of kidney function affects study medicine (PF-07923568) in the body. People with some level of loss of kidney function may process PF-07923568 differently from healthy people. PF-07923568 is developed as a possible treatment for respiratory syncytial virus (RSV) infection. RSV is a common virus that affects the lungs and usually causes mild, cold-like symptoms. RSV can cause severe lung infections in infants, elderly, and adults with other serious medical conditions.
This study is seeking participants who:
- Have less than 25% difference in kidney function between 2 screening visits.
- Meet the eGFR criteria for being assigned to groups. eGFR tells how well the kidney is filtering.
- Are not on hemodialysis. Hemodialysis is a type of treatment that helps the body remove extra fluid and waste products from the blood when the kidneys are not able to.
Participants will take the study medicine as capsules by mouth once at the study clinic. The participants will stay at the study clinic for about 5 days. During that time, the study team will monitor the participants. The study team will take some blood samples to test the level of PF-07923568. This will help us understand if some level of loss of kidney function will have an effect on the study medicine PF-07923568.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening.
- •Meet the eGFR criteria for cohort placement during the screening period.
- •Body mass index (BMI) of 16-40 kg/m2; and a total body weight >45 kg (99 lb.).
- •For Cohort 2 Normal Renal Function Group Only: At screening, meet the demographic-matching criteria, including body weight within ±15 kg and age within ±10 years, of the average of the pooled renal impairment cohort.
排除标准
- •Participants with acute renal disease.
- •Participants who are clinically nephrotic.
- •Participants requiring hemodialysis.
- •Renal allograft recipients.
- •Participants who have previously received a kidney, liver, or heart transplant.
- •Urinary incontinence without catheterization.
- •History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
- •History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- •Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
结局指标
主要结局
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: Baseline through Day 5
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
时间窗: Baseline through Day 5
Maximum Observed Plasma Concentration (Cmax)
时间窗: Baseline through Day 5
次要结局
- Number of Participants With Change From Baseline in Laboratory Tests Results(Baseline through Day 5)
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)(Baseline through Day 36)
- Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)(Baseline through Day 5)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Baseline through Day 5)