A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 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
- 3
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of PF-07817883
研究概览
简要总结
The purpose of the study is to learn about:
- how PF-07817883 is processed in the body of adult participants.
- the safety of PF-07817883.
These participants will have different levels of kidney function loss:
- moderate
- severe
- none or healthy Participants with moderate, severe or no loss of kidney function may be taken into one of 3 groups.
This study is seeking for participants who:
- are male or female of 18 to 90 years of age.
- have different levels of damage to kidney function or for one of the groups, no damage
- are willing to follow the requirements of the study including stay at clinic for 5 nights and 6 days.
About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing.
On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Male or female participants aged 18 (or the minimum age of consent in accordance with local regulations) to 90 years of age at screening.
- •BMI of ≥16 kg/m2 and a total body weight >45 kg (99 lbs).
- •Stable renal function, defined as the eGFR values obtained at the two screening visits should not be more than 25% different.
排除标准
- •Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection at the time of screening or Day -
- •History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) test due to hepatitis B vaccination is allowed.
- •Renal transplant recipients.
- •Any condition possibly affecting drug absorption
研究组 & 干预措施
Cohort 1
No renal impairment
干预措施: PF-07817883 (Drug)
Cohort 2
Severe renal impairment
干预措施: PF-07817883 (Drug)
Cohort 3
Moderate renal impairment
干预措施: PF-07817883 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
时间窗: Day 1 to Day 5
Plasma PF-07817883 PK parameters
Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
时间窗: Day 1 to Day 5
Plasma PF-07817883 PK parameters
Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
时间窗: Day 1 to Day 5
Plasma PF-07817883 parameters
次要结局
- Number of participants with Non-Serious Adverse Events (NSAE)(Screening to Day 35)
- Number of participants with Treatment Emergent Adverse Events(Day 1 to Day 35)
- Number of participants with Clinically Significant ECG Abnormalities(Day 1 to Day 5)
- Number of participants with Clinically Significant Abnormal Vital Signs(Day 1 to Day 5)
- Number of participants with Clinically Significant abnormal laboratory values.(Baseline to Day 5)
- Number of participants with Serious Adverse Events(Screening to Day 35)