A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07293893 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purposes of the study are:
To learn about the safety and tolerability of study medicine (PF-07293893). Tolerability is the extent to which side effects can be tolerated. Side effects are unwanted reactions to the study medicine.
To measure the amount of PF-07293893 in blood after the medicine is taken by mouth.
The study is seeking participants who:
- Are females of non-childbearing potential and males 18 to 65 years of age
- Are in generally healthy condition
- Have not had viral infections (HIV, HBV or HCV). HIV, human immunodeficiency virus. HBV, human hepatitis B virus. HCV, human hepatitis C virus.
Participants will receive either PF-07293893 or placebo (dummy pill) by chance. Participants will undergo up to 4 treatments periods in this study. Everyone will receive up to 4 doses of study medicine and up to 2 doses of placebo. In each period, participants will stay in study clinic for 5 days. There will be at least 2 days between each treatment period.
Participants will be involved in this study for about 14 weeks. During their stay, participants will undergo several examinations. Participants will also have their blood collected by the study doctors for several times.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PF-07293893 and Placebo (Cohort 1)
Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.
干预措施: PF-07293893 (Drug)
PF-07293893 and Placebo (Cohort 1)
Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.
干预措施: Placebo (Drug)
PF-07293893 and Placebo (Cohort 2)
Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.
干预措施: PF-07293893 (Drug)
PF-07293893 and Placebo (Cohort 2)
Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.
干预措施: Placebo (Drug)
PF-07293893 and Placebo (Cohort 3)
Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.
干预措施: PF-07293893 (Drug)
PF-07293893 and Placebo (Cohort 3)
Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug.
Number of Participants With Laboratory Test Abnormalities
时间窗: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes \<0.8\*lower limit of normal \[LLN\], lymphocytes/leukocytes \<0.8\*LLN, neutrophils \<0.8\*LLN, neutrophils/leukocytes \<0.8\*LLN, eosinophils/leukocytes \>1.2\*upper limit of normal \[ULN\], monocytes \>1.2\*ULN, monocytes/leukocytes \>1.2\*ULN); clinical chemistry (aspartate aminotransferase \>3.0\*ULN, potassium \>1.1\*ULN, creatine kinase \>2.0\*ULN); urinalysis (urine specific gravity \<1.003 ,\>1.030, ketones \>=1, urine hemoglobin \>=1, urobilinogen \>=1, urine bilirubin \>=1, leukocyte esterase \>=1). In this outcome measure, participants with any laboratory abnormalities are reported.
Number of Participants With Clinically Significant Changes in Vital Signs
时间窗: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
时间窗: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)
ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion.
次要结局
- Time for Cmax (Tmax) of PF-07293893(Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period)
- Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07293893(Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period)
- Maximum Plasma Concentration (Cmax) of PF-07293893(Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period)
- Area Under the Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893(Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period)
- Terminal Half-Life (t1/2) of PF-07293893(Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period)
