A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07817883 FOLLOWING ORAL ADMINISTRATION OF NEW FORMULATIONS RELATIVE TO THE REFERENCE FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITION
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 Plasma Concentration (Cmax) of PF-07817883
研究概览
简要总结
The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.
详细描述
This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an 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 aged 18 years or older, 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 16 to 32 kg/m2; and a total body weight >45 kg
- •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, laboratory abnormality, or other conditions and situations 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, 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, or HCVAb. Hepatitis B vaccination is allowed.
- •Positive test result for SARS-CoV-2 infection at admission
研究组 & 干预措施
Period 1 formulation 1 PF-07817883
Single oral dose of PF-07817883 tablet under fasted condition
干预措施: Drug: PF-07817883 (Drug)
Period 2 formulation 2 PF-07817883
Single oral dose of PF-07817883 tablet under fasted condition
干预措施: Drug: PF-07817883 (Drug)
Period 3 formulation 3 PF-07817883
Single oral dose of PF-07817883 tablet under fasted condition
干预措施: Drug: PF-07817883 (Drug)
Period 4 formulation 4 PF-07817883
Single oral dose of PF-07817883 tablet under fasted condition
干预措施: Drug: PF-07817883 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
时间窗: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883
时间窗: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days))
- Number of Participants With Laboratory Test Abnormalities(From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days))
- Number of Participants With Clinically Significant Abnormality in Vital Signs(From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days))
- Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)(From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days))