临床试验/NCT00510029

NCT00510029已完成1 期

Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Subjects.

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 72 人开始时间: 2007年9月最近更新: 2008年3月13日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 72
主要终点: To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The study will assess the safety, tolerability and pharmacokinetics of single intravenous (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour infusion.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 50 Years（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

GAP-134, IV and Oral

Other

Experimental; Active Comparator; Placebo

干预措施: GAP-134 (Drug)

结局指标

主要结局

To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects

时间窗: 3-4 months

次要结局

To provide the initial Pharmacokinetic (PK) profile of single ascending IV doses (24 hour and 1-minute) and the initial PK assessment of the bioavailability of an oral formulation of GAP-134 under fasting conditions in healthy subjects(3-4 months)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

相似试验

已完成

1 期

Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese MalesHealthy Subjects

NCT00722202Wyeth is now a wholly owned subsidiary of Pfizer48

已完成

1 期

Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy SubjectsHealthy

NCT00550381Wyeth is now a wholly owned subsidiary of Pfizer72

已完成

1 期

Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257Healthy Subjects

NCT00722501Wyeth is now a wholly owned subsidiary of Pfizer48

终止

1 期

Study Evaluating HTC-867 in Healthy Young and Elderly SubjectsHealthy Subjects

NCT00827489Wyeth is now a wholly owned subsidiary of Pfizer72

撤回

1 期

Study Evaluating Single Doses of GAP-134Healthy Subjects

NCT00820521Wyeth is now a wholly owned subsidiary of Pfizer