A PHASE 1, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, STUDY TO ASSESS SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING ORAL DOSES OF PF-07054894 IN HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- AEs following Single ascending dose (SAD)
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and PK of single escalating doses and multiple escalating doses of PF-07054894.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female (of non-child bearing potential) participants must be 18 to 55 years of age, inclusive, and with BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- •Male and female of non-child bearing potential participants who are overtly healthy as determined by medical evaluation.
- •Participants must be willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure, from admission to FU1 and to apply sun screen/lotion with a high sun protection factor, as appropriate.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunological/rheumatological, or allergic diseases.
- •Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB), history of HIV infection, hepatitis B, or hepatitis C.
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Have a history of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day
- •History of phototoxicity and photosensitivity.
研究组 & 干预措施
PF-07054894
Participants will receive single or multiple ascending doses of oral PF-07054894
干预措施: PF-07054894 (Drug)
Placebo
Participants will receive matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
AEs following Single ascending dose (SAD)
时间窗: Day 1 up to Day 28 (SAD)
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
AEs following multiple ascending dose (MAD)
时间窗: Day 1 up to Day 42 (MAD)
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Percentage of subjects with laboratory abnormalities
时间窗: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
Number of subjects with change from baseline in vital signs
时间窗: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
Number of subjects with change from baseline of blood pressure, pulse rate, and oral temperature
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
时间窗: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
次要结局
- Time to reach plasma Cmax (Tmax)(Day 1 (SAD) or Day 1 and Day 14 (MAD))
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Day 1 up to Day 3 (SAD))
- Maximum Plasma concentration (Cmax)(Day 1 (SAD) or Day 1 and Day 14 (MAD))
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)](Day 1 up to Day 3 (SAD))
- Dose normalized Cmax (Cmax(dn))(Day 1 (SAD) or Day 1 and Day 14 (MAD))
- Apparent Oral Clearance (CL/F)(Day 1 (SAD) or Day 14 (MAD))
- Apparent Volume of Distribution (Vz/F)(Day 1 (SAD) or Day 14 (MAD))
- Single dose and Multiple Dose PK half-life (t½)(Day 1 (SAD) or Day 14 (MAD))
- Observed Accumulation Ratio for Cmax (Rac,Cmax)(MAD, Day 14)
- Observed Accumulation Ratio for AUCτau (Rac, AUCτau)(MAD, Day 14)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCτau)(Day 1 and Day 14 of MAD)
- Minimum Observed Plasma Trough Concentration (Cmin)(Day 1 up to Day 14 of MAD)
- Multiple dose PK/AUCτau (dn)(Day 1 and Day 14 of MAD)
- Cumulative Amount of Drug Recovered Unchanged in Urine during dosing interval (Ae,τau)(MAD, Day 14)
- Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τau (Ae,τau%)(MAD, Day 14)
- Renal Clearance (Clr)(MAD, Day 14)