A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07321332 BOOSTED WITH RITONAVIR IN ADULT PARTICIPANTS WITH MODERATE HEPATIC IMPAIRMENT AND HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332
研究概览
简要总结
The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of hepatic impairment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants who are classically healthy having no clinically relevant abnormalities. No known or suspected hepatic impairment
- •Stable hepatic impairment that meets the criteria for Class B of the Child-Pugh Classification
排除标准
- •Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
- •Participants who have been vaccinated with COVID-19 vaccines within the past week of dosing
- •A positive urine drug test, for illicit drugs, at Screening
- •History of sensitivity reactions to ritonavir or any of the formulation components of PF-07321332 or ritonavir.
- •eGFR <60 mL/min/1.73m2 based on the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥ upper limit of normal (ULN) (for healthy participants); AST or ALT > 5x ULN (for hepatic impairment participants)
- •Albumin > ULN (for healthy participants);
- •Prothrombin time > ULN (for healthy participants);
- •Total bilirubin level ≥1.5 × ULN [NOTE: Participants with a history of Gilbert syndrome (and hence elevated total bilirubin) are eligible provided direct bilirubin level is ≤ ULN).
研究组 & 干预措施
Cohort 1
Healthy Volunteer
干预措施: PF-07321332 (Drug)
Cohort 1
Healthy Volunteer
干预措施: Ritonavir (Drug)
Cohort 2
Hepatic Impairment
干预措施: PF-07321332 (Drug)
Cohort 2
Hepatic Impairment
干预措施: Ritonavir (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332
时间窗: Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hours
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation was expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-07321332
时间窗: Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hours
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation was expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-07321332
时间窗: Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hours
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation was expressed in percentage.
次要结局
- Number of Participants With an Treatment Emergent Adverse Event (TEAE)(Up to 2 months)
- Number of Participants With Abnormal Electrocardiograms (ECGs)(Up to 2 months)
- Number of Participants With Abnormal Vital Signs(Up to 2 months)
- Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)(Up to 2 months)