A Phase 1, Open-Label, 2-Period, Fixed Sequence Study to Estimate the Effect of Itraconazole on the Pharmacokinetics of PF-07817883 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) of PF-07817883
研究概览
简要总结
The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults.
This study is seeking participants who are:
- male and female aged 18 to 65 years old,
- overtly healthy. This can be determined my medical evaluation, medical history, lab tests etc.
This study will consist of 2 parts, Period 1 and Period 2.
Period 1: participants will take PF-07817883 one time by mouth at the study clinic.
Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days.
Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants' reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883.
Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors.
详细描述
This is a Phase 1, open-label, 2-period, fixed sequence study to estimate the effect of itraconazole, a strong CYP3A4 inhibitor, on the plasma PK of PF-07817883 in healthy adults. The study will consist of 2 treatments: a single oral dose of PF-07817883 alone and a single oral dose of PF-07817883 in combination with multiple oral doses of itraconazole. The PK and safety will be assessed and compared for single dose of PF-07817883 in period 1 and period 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking: None (open label)
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
- •Male and female participants aged 18 to 65 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
- •BMI of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lb).
- •Capable of giving signed informed consent.
排除标准
- •Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, CV, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- •Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- •Positive test result for SARS-CoV-2 infection at admission.
研究组 & 干预措施
Period 1
The treatment arm includes a single dose of PF-07817883 (Period 1 Day 1)
干预措施: PF-07817883 (Drug)
Period 2
This treatment arm includes 7-day dosing of itraconazole with a single dose of PF-07817883 Co-administered on Day 4 (Period 2 Day 4)
干预措施: PF-07817883 (Drug)
Period 2
This treatment arm includes 7-day dosing of itraconazole with a single dose of PF-07817883 Co-administered on Day 4 (Period 2 Day 4)
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of PF-07817883
时间窗: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4
Cmax was observed directly from data and measured in nanogram per milliliter (ng/mL).
Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
时间窗: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4
AUCinf was derived by AUClast + (Clast\*/kel). AUClast was area under the plasma concentration-time profile from time 0 to the time of Clast; Clast\* was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUCinf was measured in nanogram\*hour per milliliter (ng\*hr/mL).
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Day 1 of dosing up to 35 days post last dose of study intervention (maximum up to 48 days))
- Number of Participants With Laboratory Test Abnormalities(Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days))
- Number of Participants With Electrocardiogram (ECG) Findings Per Pre-defined Criteria(Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days))
- Number of Participants With Vital Signs Findings Per Pre-defined Criteria(Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days))
- Number of Participants With Clinically Significant Abnormalities in Physical Examination(Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days))
- Time to Reach Cmax (Tmax) of PF-07817883(Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4)
- Terminal Phase Half-Life (t1/2) of PF-07817883(Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4)
- Apparent Clearance (CL/F) of PF-07817883(Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4)
- Apparent Volume of Distribution (Vz/F) of PF-07817883(Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4)