A PHASE 1, OPEN-LABEL, NON-RANDOMIZED STUDY TO INVESTIGATE THE SAFETY AND PK FOLLOWING MULTIPLE ORAL DOSES OF PF-07321332 (NIRMATRELVIR)/RITONAVIR IN ADULT PARTICIPANTS WITH COVID-19 AND SEVERE RENAL IMPAIRMENT EITHER ON HEMODIALYSIS OR NOT ON HEMODIALYSIS
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 15
- 试验地点
- 52
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
研究概览
简要总结
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment. The study will also look at the amounts of study drug in your blood. There will be 24 participants in this study; 12 of them will have severe renal impairment and not be on hemodialysis and 12 of them will be on hemodialysis.
All participants in this study will take PF-07321332 (nirmatrelvir)/ritonavir by mouth for 5 days. During this time, they will have to collect blood samples to measure the study drug levels in their blood. After taking the study drug for 5 days, the participants will have follow-up visits for about another 28 days for a total of about 34 days in the study. The study team will check how each participant is doing during regular visits at the study clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Covid-19 infection
- •Severe kidney disease (on hemodialysis or not on hemodialysis)
排除标准
- •Hospitalized
- •Take medications that are not allowed
- •Renal transplant patients
- •HIV infection
- •This is not a complete list. Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
干预措施: PF-07321332 (nirmatrelvir)/ritonavir (Drug)
PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
干预措施: PF-07321332 (nirmatrelvir)/ritonavir (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
时间窗: From start of treatment on Day 1 to Day 34
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the following criteria: 1. results in death. 2. is life-threatening. 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant disability/incapacity. 5. Is a congenital anomaly/birth defect. 6. Is a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic. 7. other important medical events. Any events occurring following start of treatment were considered treatment emergent.
Number of Participants With Permanent Discontinuation From Study or Study Intervention Due to Adverse Events and Serious Adverse Events
时间窗: From start of treatment on Day 1 to Day 34
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the following criteria: 1. results in death. 2. is life-threatening. 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant disability/incapacity. 5. Is a congenital anomaly/birth defect. 6. Is a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic. 7. other important medical events. Any events occurring following start of treatment were considered treatment emergent.
Maximum Plasma Concentration (Cmax) of PF-07321332 (Nirmatrelvir)
时间窗: Treatment Day 1 to Day 5, see description for details
Nirmatrelvir plasma concentration data were analyzed using nonlinear mixed effects models. Time frame was: For Cohort 1: Day 1 (anytime between 1-3 hours post-dose), Day 2 (anytime between 4-8 hours post-dose), Day 3 (anytime between 9-15 hours post-dose), Day 4 (pre-dose, anytime between 1-4 hours post-dose), Day 5 (pre-dose, anytime between 0.5-6 hours post-dose, anytime between 9-15 hours post-dose). For Cohort 2: Day 1 (anytime between 1-3 hours post-dose), Day 3 (pre-HD), Day 4 (pre-HD, pre-dose, anytime between 0.5-3 hours post-dose, anytime between 4-8 hours post-dose, anytime between 9-15 hours post-dose).
Apparent Volume of Distribution (Vz/F) of Nirmatrelvir
时间窗: Treatment Day 1 to Day 5
Vz/F was estimated at steady state.
Area Under the Curve Over a Dosing Interval (AUC0-tau) of Nirmatrelvir
时间窗: 24 Hours after each dose on Treatment Day 1 to Day 5
AUC0-tau was measured at 24 hours post-dose.
Terminal Half-Life (T1/2) of Nirmatrelvir
时间窗: Treatment Day 1 to Day 5
T1/2 was observed directly from data.
Trough Concentration (Ctrough) of Nirmatrelvir
时间窗: 24 Hours after each dose on Treatment Day 1 to Day 5
Ctrough was measured at 24 hours post-dose (pre the next dose). It was analyzed using nonlinear mixed effect models.
次要结局
- Hemodialysis Clearance (CLd) of Nirmatrelvir(Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4)
- Fraction of Drug Removed During Dialysis (Fd) of Nirmatrelvir(Pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose on Day 3 and Day 4)