A Phase 1, Single Center, Open-label Study of PF-07321332 Administrated as Multiple Oral Doses in Healthy Chinese Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1
研究概览
简要总结
The purpose of this Phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of PF-07321332 when PF-07321332 and ritonavir are given to healthy adult Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese participants
- •No clinical relevant abnormalities
- •Body mass index (BMI):17.5-28
排除标准
- •Any clinical significant illness
- •History of alcohol abuse
- •Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose
- •Abnormal clinical lab tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, estimated glomerular filtration rate (eGFR)
- •Abnormal vital signs, such 12-electrocardiogram (ECG), blood pressure and pulse rate
- •Blood donation within 60 days
- •History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb)
- •Other medical or psychiatric may inappropriate for the study
研究组 & 干预措施
PF-07321332/ritonavir
PF-07321332/ritonavir will be given by mouth two times a day for 10 days to adult Chinese healthy volunteers
干预措施: PF-07321332/ritonavir (Drug)
结局指标
主要结局
PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1
时间窗: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Cmax is maximum plasma concentration .
PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Cmax is maximum plasma concentration
PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1
时间窗: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Tmax is the time for maximum plasma concentration
PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Tmax is the time for maximum plasma concentration
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1
时间窗: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Area under the plasma concentration-time profile from time Zero to time point on 12 hours
PF-07321332 Peak-to-trough Ratio (PTR) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
This was determined by Day 10 Cmax/Day 10 Ctrough.
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.
PF-07321332 Apparent Clearance (CL/F) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Apparent oral clearance. This was determined by Dose/AUCtau.
PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
This was determined by AUCtau/tau.
PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Apparent oral volume of distribution.
PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10
时间窗: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.
PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10
时间窗: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.
PF-07321332 Terminal Elimination Half-life (t½) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10
时间窗: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)
PF-07321332 Trough Concentration (Ctrough) on Day 5
时间窗: Day 5 (pre-dose)
Concentration at pre-dose on Day 5. Observed directly from data.
PF-07321332 Trough Concentration (Ctrough) on Day 8
时间窗: Day 8 (pre-dose)
Concentration at pre-dose on Day 8. Observed directly from data.
PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)
时间窗: Day 10 (pre-dose)
Concentration at pre-dose on Day 10. Observed directly from data.
PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)
时间窗: Day 10 (12 hours after last dose)
Concentration at 12 hour time on Day 10. Observed directly from data.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From baseline up to Day 42)
- Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria(Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose))
- Number of Participants With Laboratory Abnormalities(Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.)
- Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria(Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose))
- Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1(Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours))
- Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10(Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours))
- Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1(Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours))
- Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10(Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours))
- Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1(Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours))
- Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10(Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours))
- Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10(Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours))
- Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10(Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours))
- Ritonavir Apparent Clearance (CL/F) on Day 10(Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours))
- Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10(Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours))
- Ritonavir Terminal Elimination Half-life (t½) on Day 10(Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours))
- Ritonavir Trough Concentration (Ctrough) on Day 5(Day 5 (pre-dose))
- Ritonavir Trough Concentration (Ctrough) on Day 8(Day 8 (pre-dose))
- Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)(Day 10 (pre-dose))
- Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)(Day 10 (12 hours after last dose))