A PHASE 1, OPEN-LABEL, 3-TREATMENT, 6-SEQUENCE, 3-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF PF-07321332/RITONAVIR AND RITONAVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax)
研究概览
简要总结
This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Body Mass Index (BMI) of 17.5 to 30.5 kg.m2; and a total body weight >50 kg (110 lbs)
- •Female participants must have a negative pregnancy test
排除标准
- •Positive test for SARS-Co-V2 at the time of screening or Day -1
- •Active pathological bleeding or risk of bleeding
- •Positive urine drug test
- •History of sensitivity to heparin or heparin induced thrombocytopenia
- •Participants who have been vaccinated for COVID-19 in the past 7 days
研究组 & 干预措施
Treatment A
Dabigatran only
干预措施: Dabigatran (Drug)
Treatment B
PF-07321332/ritonavir + Dabigatran
干预措施: PF-07321332/ritonavir + Dabigatran (Drug)
Treatment C
Ritonavir + Dabigatran
干预措施: Ritonavir + Dabigatran (Drug)
结局指标
主要结局
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax)
时间窗: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Cmax was defined as maximum observed plasma concentration.
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUCinf
时间窗: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
AUCinf was defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUClast
时间窗: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.
次要结局
- Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality)(From pre-dose on Day 1 to Day 3)
- Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUCinf(Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose)
- Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUClast(Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose)
- Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Maximum Plasma Concentration (Cmax)(Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose)
- Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Tmax(Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose)
- Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): t½(Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose)
- Number of Participants With Vital Signs of Potential Clinical Concern(From pre-dose on Day 1 to Day 3)
- Plasma PF-07321332 PK Parameters: AUCtau(Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose)
- Plasma PF-07321332 PK Parameters: t½(Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose)
- Plasma PF-07321332 PK Parameters: Vz/F(Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study(From Pre-dose on Day 1 to Day 48)
- Number of Participants With ECG Values of Potential Clinical Concern(From pre-dose on Day 1 to Day 3)
- Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Time to First Occurrence of Cmax (Tmax)(Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose)
- Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Terminal Half-life (t½)(Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose)
- Plasma PF-07321332 PK Parameters: Cmax(Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose)
- Plasma PF-07321332 PK Parameters: CL/F(Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose)
- Plasma PF-07321332 PK Parameters: Tmax(Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose)