A Phase 1, Open-Label, Randomized, 5-Period, 6-Sequence, Crossover Study to Compare the Single-Dose Pharmacokinetics of One Immediate-Release and Two Modified-Release Formulations of PF-08049820 Administered Orally to Healthy Adult Participants Under Fasted and Fed Conditions
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
- Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of PF-08049820 in the fasted state
研究概览
简要总结
The purpose of this study is to see how different forms of a medicine called PF-08049820 move through the body when taken by mouth. The scientists want to see:
- How well is the medicine absorbed when it's made in different ways (fast vs. slow release)
- If eating a high-fat meal changes how the medicine moves through the body The results of this study will help decide which version of the medicine is best for future studies.
This study is seeking participants who:
- are men and women who can't have children
- are 18 years or older
- weigh more than 99 pounds (45 kg)
- have a healthy body weight (not too low or too high)
- are generally healthy with no serious medical problems. People with serious health problems, recent drug use, or who had certain vaccines recently cannot join.
- are willing to follow all the study rules
Each participant will try 5 different versions of the medicine, one at a time. There will be 3 days between each dose to make sure the medicine is out of the system. The medicine will be tested in different forms:
- Immediate-release tablet (works quickly)
- Short-release tablet (works slowly)
- Long-release tablet (works even slower)
Some versions will be taken without food, and others after eating a high-fat meal. After each dose, doctors will take blood samples for up to 72 hours to see how the medicine moves through the body. The whole study will take about 6 to 11 weeks and participants will stay overnight in the clinic for about 17 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open label study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants of non-childbearing potential ≥18 years of age
- •BMI of 16-32 kg/m2; and a total body weight >45 kg (99 lbs)
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Exclusion Criteria
- •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).
- •Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- •History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBsAb, HBcAb, or HCVAb. A positive HBsAb result and a history of Hepatitis B vaccination is allowed.
- •Use of certain prescription or nonprescription drugs and dietary (e.g. grapefruit) and herbal supplements within up to 14 days or 5 half-lives, whichever is longer, prior to the first dose of study intervention.
- •Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
- •Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- •History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
排除标准
- 未提供
研究组 & 干预措施
Treatment A
Participants will receive a single dose of PF-08049820 short Modified release (MR) release rate (MR1) tablets under fasted conditions.
干预措施: PF-08049820 MR1 (Drug)
Treatment B
Participants will receive a single dose of PF-08049820 long MR release rate (MR2) tablets under fasted conditions.
干预措施: PF-08049820 MR2 (Drug)
Treatment C
Participants will receive a single dose of PF-08049820 Immediate Release (IR) tablets under fasted conditions.
干预措施: PF-08049820 IR (Drug)
Treatment D
Participants will receive a single dose of PF-08049820 MR2 tablets under fed conditions.
干预措施: PF-08049820 MR2 (Drug)
Treatment E
Participants will receive a single dose of PF-08049820 IR tablets under fed conditions.
干预措施: PF-08049820 IR (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of PF-08049820 in the fasted state
时间窗: Pre-dose until 72 hours post dose
PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fasted state
时间窗: Pre-dose until 72 hours post dose
次要结局
- PK: Plasma Area Under the Concentration Versus Time Curve (AUC) of PF-08049820 in the fed state(Pre-dose until 72 hours post dose)
- PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fed state(Pre-dose until 72 hours post dose)
- Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(First dose, up to follow up visit (28-35 days post last dose))
- Number of Participants With Clinical Laboratory Abnormalities(Baseline, up to Day 16)
- Number of Participants With Vital Signs Abnormalities(Baseline, up to Day 16)
- Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings(Baseline, up to Day 16)