临床试验/NCT01133574

NCT01133574终止1 期

A Double-Blind, Randomized, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of SLV354 After Oral Dose Administration in Healthy Adult Male Subjects

Abbott1 个研究点分布在 1 个国家目标入组 47 人开始时间: 2010年2月最近更新: 2011年8月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Abbott
入组人数: 47
试验地点: 1
主要终点: Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)

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研究点记录与标识符相似试验

研究概览

简要总结

This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)

详细描述

The Part A of this study is a parallel design followed in a second part by a cross-over design

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: Male
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

B1-2

Experimental

Part B, Cross-over design, Arm 2

干预措施: SLV354 capsules (Drug)

A1

Experimental

Part A, Parallel design Arm 1

干预措施: SLV354 capsules (Drug)

A2

Experimental

Part A, Parallel design Arm 2

干预措施: SLV354 capsules (Drug)

A3

Experimental

Part A, Parallel design Arm 3

干预措施: SLV354 capsules (Drug)

A4

Experimental

Part A, Parallel design Arm 4

干预措施: SLV354 capsules (Drug)

A5

Experimental

Part A, Parallel design Arm 5

干预措施: SLV354 capsules (Drug)

A6

Experimental

Part A, Parallel design Arm 6

干预措施: SLV354 capsules (Drug)

A7

Experimental

Part A, Parallel design Arm 7

干预措施: SLV354 capsules (Drug)

A8

Experimental

Part A, Parallel design Arm 8

干预措施: SLV354 capsules (Drug)

A9

Placebo Comparator

Part A, Parallel design Arm 9

干预措施: Placebo capsules (Drug)

B1-1

Experimental

Part B, Cross-over design, Arm 1

干预措施: SLV354 capsules (Drug)

B2-1

Experimental

Part B, Cross-over design, Arm 3

干预措施: SLV354 capsules (Drug)

B2-2

Experimental

Part B, Cross-over design, Arm 4

干预措施: SLV354 capsules (Drug)

B3

Placebo Comparator

Part B, Cross-over design, Arm 5

干预措施: Placebo capsules (Drug)

结局指标

主要结局

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)

时间窗: 1 week after each dose level

Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)

时间窗: 2 weeks after each dose

次要结局

Pharmacokinetic parameters (AUC and Cmax) after single ascending oral dosing of max. 8 doses of SLV354 ranging from 20 to 1250 mg (Part A)(1 week after each dose level)
Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)(1 week after each dose level)
Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B)(2 weeks after each dose)
Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)(2 weeks after each dose)

研究者

发起方

Abbott

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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