AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, TWO-COHORT, TWO-PERIOD, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE AND PROBENECID ON THE PHARMACOKINETICS OF SINGLE DOSE PF-07220060 ADMINISTERED UNDER THE FED CONDITION TO HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Plasma PF-07220060 Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of the study is to see and learn the effect of multiple doses of a strong CYP3A4 inhibitor and a potent UGT2B7 inhibitor on the PK of PF-07220060.
详细描述
This study is seeking participants who are:
1. male and female aged 18 to 65 years and are healthy as confirmed by medical tests 2. with body mass index (BMI) of 17.5-30.5 kilogram per meter squared (kg/m2); and a total body weight of more than 50 kilograms (110 pounds).
The study will consist of 2 groups each containing 2 periods. In both groups, participants will receive a single dose of PF-07220060 in Period 1. In group 1 Period 2, itraconazole will be given once a day from Day 1 to Day 9. On the morning of Period 2 Day 4, a single dose of PF 07220060 will be taken by mouth immediately after itraconazole is taken by mouth. In group 2 Period 2, probenecid will be given 4 times a day from Day 1 to Day 9. On the morning of Period 2 Day 3, a single dose of PF 07220060 will be taken by mouth, immediately after probenecid is taken by mouth.
In both groups, PF-07220060 will be given by mouth about 30 minutes after a moderate fat standard calorie meal in Period 1. In cohort 1 Period 2, itraconazole will be given by mouth once a day from Day 1 to Day 9 about 30 minutes after a moderate fat standard calorie meal. On the morning of Period 2 Day 4, a single dose of PF 07220060 will be administered by mouth immediately after itraconazole administration. In cohort 2 Period 2, probenecid will be given by mouth 4 times a day (QID) with 6±2 hours intervals from Day 1 to Day 9 with or without food. On Period 2 Day 2, the last probenecid dose prior to the Day 3 first dose will be given under fasted condition. On the morning of Period 2 Day 3, after 10 hours fasting, ~30 min after a moderate fat standard calorie breakfast, a single dose of PF-07220060 will be administered by mouth, immediately after probenecid administration.
The study will look at the effect of multiple doses of itraconazole and probenecid on how the body processes a single oral dose of PF-07220060.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 2, Period 2: PF-07220060 probenecid
In Cohort 2, Period 2, participants will receive oral dose of probenecid four times a day from Day 1 to Day 9. On the morning of Day 3, participants will first receive one oral dose of probenecid followed by a single oral dose of PF-07220060 tablet.
干预措施: Probenecid (Drug)
Cohort 1, Period 1: PF-07220060
In Cohort 1, Period 1 participants will receive a single dose of PF-07220060 tablet given orally and administered with food on Day 1.
干预措施: PF-07220060 (Drug)
Cohort 1, Period 2: PF-07220060 and itraconazole
In Cohort 1 Period 2, participants will receive oral dose of itraconazole once daily from Day 1 to Day 9. On the morning of Day 4, participants will first receive one oral dose of itraconazole followed by a single oral dose of PF-07220060 tablet
干预措施: PF-07220060 (Drug)
Cohort 1, Period 2: PF-07220060 and itraconazole
In Cohort 1 Period 2, participants will receive oral dose of itraconazole once daily from Day 1 to Day 9. On the morning of Day 4, participants will first receive one oral dose of itraconazole followed by a single oral dose of PF-07220060 tablet
干预措施: Itraconazole (Drug)
Cohort 2, Period 1: PF-07220060
In Cohort 2, Period 1 participants will receive a single dose of PF-07220060 tablet given orally and administered with food on Day 1.
干预措施: PF-07220060 (Drug)
Cohort 2, Period 2: PF-07220060 probenecid
In Cohort 2, Period 2, participants will receive oral dose of probenecid four times a day from Day 1 to Day 9. On the morning of Day 3, participants will first receive one oral dose of probenecid followed by a single oral dose of PF-07220060 tablet.
干预措施: PF-07220060 (Drug)
结局指标
主要结局
Plasma PF-07220060 Maximum Observed Plasma Concentration (Cmax)
时间窗: Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post PF-07220060 dose for Period 1; Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post PF-07220060 dose for Period 2
Plasma PF-07220060 Area under the plasma concentration versus time curve (AUC)
时间窗: Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post PF-07220060 dose for Period 1; Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours post PF-07220060 dose for Period 2
次要结局
- Number of Participants With Laboratory Abnormalities(From baseline up to 28 to 35 days after last dose of investigational drug)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(From baseline up to 28 to 35 days after last dose of investigational drug)
- Number of Participants With Treatment-Emergent Adverse Events (AEs)(From baseline up to 28 to 35 days after last dose of investigational drug)
- Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings(From baseline up to 28 to 35 days after last dose of investigational drug)
- Number of participants taking concomitant medications(From baseline up to 28 to 35 days after last dose of investigational drug)