A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of safety and tolerability of PF-04287881 after single oral dose.
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
- •Women of non-childbearing potential only.
- •Japanese subjects muct have 4 Japanese grandparents who were born in Japan.
排除标准
- •Previous antibiotic use within 14 days prior to dosing.
- •Use of antibiotics during hospitalization within 90 days prior to dosing.
- •History of sensitivity to macrolides or ketolides.
- •Presence of clinically significant eye conditions (other than corrective lenses).
研究组 & 干预措施
Cohort 1
干预措施: PF-04287881 (Drug)
Cohort 1
干预措施: Placebo (Drug)
Cohort 2
干预措施: PF-04287881 (Drug)
Cohort 2
干预措施: Placebo (Drug)
Cohort 8
Japanese volunteers, low dose previously tested (based on PK)
干预措施: Placebo (Drug)
Cohort 3
干预措施: PF-04287881 (Drug)
Cohort 3
干预措施: Placebo (Drug)
Cohort 4
干预措施: PF-04287881 (Drug)
Cohort 4
干预措施: Placebo (Drug)
Cohort 5
干预措施: PF-04287881 (Drug)
Cohort 5
干预措施: Placebo (Drug)
Cohort 6
干预措施: PF-04287881 (Drug)
Cohort 6
干预措施: Placebo (Drug)
Cohort 7
干预措施: PF-04287881 (Drug)
Cohort 7
干预措施: Placebo (Drug)
Cohort 8
Japanese volunteers, low dose previously tested (based on PK)
干预措施: PF-04287881 (Drug)
Cohort 9
Japanese volunteers, intermediate dose previously tested (based on PK)
干预措施: PF-04287881 (Drug)
Cohort 9
Japanese volunteers, intermediate dose previously tested (based on PK)
干预措施: Placebo (Drug)
Cohort 10
Japanese volunteers, high dose previously tested (based on safety)
干预措施: PF-04287881 (Drug)
Cohort 10
Japanese volunteers, high dose previously tested (based on safety)
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of safety and tolerability of PF-04287881 after single oral dose.
时间窗: Daily up to discharge, follow-up 7-10 days after dosing
次要结局
- Pharmacokinetics of PF-04287881 after a single oral dose.(Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.)