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 UNDER FASTED AND FED CONDITIONS (PART A), AND A FIXED SEQUENCE STUDY TO ASSESS THE EFFECT OF RABEPRAZOLE ON THE PHARMACOKINETICS OF PF-08049820 (PART B), IN HEALTHY ADULTS
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
研究概览
简要总结
The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid.
The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose.
In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A.
The study is seeking participants who:
- Are males or females,
- Are at least 18 years of age,
- Have a body mass index (BMI) 16 to 32 kilograms per meter squared (kg/m2). Have a total body weight of more than 50 kilograms (kg) (110 pounds).
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
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
- •Healthy males and females.
- •At least 18 years of age
- •Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.).
排除标准
- •Evidence or history of clinically significant medical conditions.
- •History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B or hepatitis C.
- •History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- •Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
研究组 & 干预措施
Sequence 1 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
干预措施: PF-08049820 (Drug)
Sequence 2 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
干预措施: PF-08049820 (Drug)
Sequence 3 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
干预措施: PF-08049820 (Drug)
Sequence 4 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
干预措施: PF-08049820 (Drug)
Sequence 5 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
干预措施: PF-08049820 (Drug)
Sequence 6 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
干预措施: PF-08049820 (Drug)
Sequence 7 (Optional Part B)
3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions.
干预措施: PF-08049820 (Drug)
Sequence 7 (Optional Part B)
3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions.
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
时间窗: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A: Evaluate the relative bioavailability of different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
时间窗: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Maximum observed plasma concentration (Cmax)
时间窗: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Baseline up to Day 48 for Part A and up to Day 56 for optional Part B)
- Number of Participants With Serious Adverse Events (SAEs)(Baseline up to Day 48 for Part A and up to Day 56 for optional Part B)
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities(Baseline up to Day 16 for Part A and up to Day 24 for optional Part B)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Baseline up to Day 16 for Part A and up to Day 24 for optional Part B)
- Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings(Baseline up to Day 16 for Part A and up to Day 24 for optional Part B)
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)(Baseline up to Day 16 for Part A)
- Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit(Baseline up to Day 16 for Part A)
- Maximum observed plasma concentration (Cmax)(Baseline up to Day 16 for Part A)