NCT00820092已完成1 期
A Phase 1,Dose Escalation Study to Compare the Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Profiles of the 24-hour Intravenous Administration of Xerecept in Healthy Japanese and Caucasian Adult Volunteers
Celtic Pharma Development Services1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration
研究概览
简要总结
- To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects
- To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects
详细描述
none needed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female Japanese subjects who are citizens of Japan
- •Healthy male and female Caucasian subjects
- •Age range 20-45 years
- •BMI >19 and <27 kg/m squared
排除标准
- •Female subjects must not be pregnant at the time of study and use adequate birth control methods before,during and 4 weeks after the study
- •Subjects must be negative for HCV and HIV
- •Subjects must have negative urine tests for drugs of abuse and alcohol at screening
- •Subjects must not have any clinically significant medical conditions
研究组 & 干预措施
Xerecept 1.0
Active Comparator
1.0 ug/kg/hr hCRF -24 hour IV infusion
干预措施: Xerecept 1.0 (Drug)
Xerecept 2.0
Active Comparator
2.0 ug/kg/hr-24 hour IV infusion
干预措施: Xerecept 2.0 (Drug)
Xerecept 3.0
Active Comparator
3.0 ug/kg/hr-24 hour infusion
干预措施: Xerecept 3.0 (Drug)
结局指标
主要结局
Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and RhabdomyosarcomaDesmoplastic Small Round Cell TumorRhabdomyosarcomaNCT04095221Memorial Sloan Kettering Cancer Center21
已完成
1 期
Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain MetastasesBrain MetastasesNCT02215512EpicentRx, Inc.29
已完成
1 期
Safety and Pharmacokinetic Study of RRx-001 in Cancer SubjectsMalignant Solid TumorLymphomasNCT01359982EpicentRx, Inc.26
终止
1 期
Study of Intrathecal Administration of Onasemnogene Abeparvovec-xioi for Spinal Muscular AtrophySpinal Muscular AtrophyNCT03381729Novartis Gene Therapies32
已完成
1 期
Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic CancerPancreatic Cancer MetastaticPancreatic Cancer Stage IVStage IV Pancreatic CancerNCT03412799Panbela Therapeutics, Inc.50