AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF A SINGLE ORAL DOSE OF ARV-471 (PF-07850327) ON THE PHARMACOKINETICS OF ROSUVASTATIN IN HEALTHY PARTICIPANTS
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 Plasma Concentration (Cmax) of Rosuvastatin
研究概览
简要总结
The purpose of this study is to understand if ARV-471 affects how a BCRP substrate (rosuvastatin) gets into the body in healthy adults.
All participants in this study will receive one dose of rosuvastatin alone by mouth in Period 1. In Period 2, everyone will receive one dose of ARV-471 by mouth 90 min before one dose of rosuvastatin by mouth. The levels of rosuvastatin in Period 1 will be compared to the levels of rosuvastatin in Period 2 to determine if ARV-471 affects how rosuvastatin gets into the body differently in healthy adults.
All participants will stay at the study clinic for 10 days and 9 nights.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Male and/or female participants of non-childbearing potential must be 18 to 65 years of age, inclusive at the time of signing informed consent document.
- •Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical exam, laboratory tests, vital sign and standard 12-lead ECGs.
- •BMI of 17.5 to 32 kg/m2; and a total body weight ≥45 kg.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Pregnant female participants; breastfeeding female participants; Male participants with partners currently pregnant; fertile male participants who have partners of childbearing potential and are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.
- •Participants with known history of hypersensitivity to statin medication, sensitivity to ARV-471 or rosuvastatin or any of the formulation components of ARV-471 or rosuvastatin.
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- •A positive urine drug test.
- •History of use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
- •History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- •Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
研究组 & 干预措施
Rosuvastatin with/without ARV-471
Rosuvastatin administered as a single dose in Period 1 and Period 2. ARV-471 administered as a single dose in Period 2.
干预措施: ARV-471 (Drug)
Rosuvastatin with/without ARV-471
Rosuvastatin administered as a single dose in Period 1 and Period 2. ARV-471 administered as a single dose in Period 2.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Rosuvastatin
时间窗: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post dose on Day 1 in Periods 1 and 2
Cmax was defined as maximum plasma concentration. Cmax of rosuvastatin was observed directly from data.
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rosuvastatin
时间窗: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post dose on Day 1 in Periods 1 and 2
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast of rosuvastatin was determined using Linear/Log trapezoidal method.
次要结局
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days))
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days))
- Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)(Baseline (Period 1 Day -1) up to Period 2 Day 4 (10 days))
- Number of Participants With Electrocardiogram (ECG) Abnormalities(Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days))