A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PNU-100480 (PF-02341272) After First Time Administration Of Ascending Oral Doses To Healthy Adult Subjects Under Fed And Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Evaluation of safety and tolerability of escalating single oral doses of PNU-100480.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, 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
- •Healthy adult volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
- •Women of non-childbearing potential only.
排除标准
- •History of hypersensitivity to, or intolerance of, linezolid.
- •Antibiotic treatment within 14 days prior to dosing.
研究组 & 干预措施
Cohort 1, Sequence 1
Period 1- Placebo Period 2- 100 mg Period 3- 300 mg
干预措施: Placebo (Drug)
Cohort 1, Sequence 1
Period 1- Placebo Period 2- 100 mg Period 3- 300 mg
干预措施: PNU-100480 (Drug)
Cohort 1, Sequence 2
Period 1- 35 mg Period 2- Placebo Period 3- 300 mg
干预措施: PNU-100480 (Drug)
Cohort 1, Sequence 2
Period 1- 35 mg Period 2- Placebo Period 3- 300 mg
干预措施: Placebo (Drug)
Cohort 1, Sequence 3
Period 1- 35 mg Period 2- 100 mg Period 3- Placebo
干预措施: PNU-100480 (Drug)
Cohort 1, Sequence 3
Period 1- 35 mg Period 2- 100 mg Period 3- Placebo
干预措施: Placebo (Drug)
Cohort 2, Sequence 1
Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
干预措施: PNU-100480 (Drug)
Cohort 2, Sequence 1
Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
干预措施: Placebo (Drug)
Cohort 2, Sequence 2
Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
干预措施: PNU-100480 (Drug)
Cohort 2, Sequence 2
Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
干预措施: Placebo (Drug)
Cohort 2, Sequence 3
Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)
干预措施: PNU-100480 (Drug)
Cohort 2, Sequence 3
Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of safety and tolerability of escalating single oral doses of PNU-100480.
时间窗: Daily, Days 1-3 or 4, and 7-14 days after dosing.
次要结局
- Characterize pharmacokinetics of single oral doses PNU-100480.(Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.)
- Characterize the effect of food on the pharmacokinetics of a single oral dose of PNU-100480.(Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.)
- Characterize the bactericidal activity in blood of orally administered PNU-100480 against intracellular Mycobacterium tuberculosis in relation to blood concentrations of PNU-100480 (and its metabolites) (some periods only)(Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods))