NCT00366288已完成不适用
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Healthy Young and Healthy Elderly Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 56 人开始时间: 2006年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
This study is to evaluate the safety and tolerability of single, ascending doses of PAZ-417 in healthy young and healthy elderly subjects. The effect of a high fat meal on the metabolism of PAZ-417 will also be studied, along with blood levels of PAZ-417 . Changes in cognitive function will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Men or women, aged 18 to 50 years inclusive (healthy young subjects) and > 65 years inclusive (elderly subjects) on study day
- •Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with estradiol ≤25 pg/mL[92 pmol/L] and FSH ≥40 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile or post-menopausal must provide documentation of the procedure by an operative report or by ultrasound and have a negative serum pregnancy test result within 48 hours before administration of test article.
- •The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well-controlled, and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results which are associated with stable, chronic, well-controlled, medical conditions.
- •The estimated creatinine clearance must be within the age-appropriate normal range.
- •Exclusions Criteria:
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
- •Exclude subjects with a history of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (e.g., rheumatoid arthritis), hematologic disorders, and bleeding disorders (e.g., hemophilia, idiopathic thrombocytopenic purpura, von willebrand's disease).
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: PAZ-417 (Drug)
2
干预措施: PAZ-417 (Drug)
3
干预措施: PAZ-417 (Drug)
4
干预措施: PAZ-417 (Drug)
5
干预措施: PAZ-417 (Drug)
6
干预措施: PAZ-417 (Drug)
7
干预措施: PAZ-417 (Drug)
研究者
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