NCT00197093已完成1 期
A Placebo Controlled, Double-Blind, Randomised Study Investigating the Safety, Tolerability and Pharmacokinetics of Ascending Multiple Oral Doses of SB-773812 in Male and Female Schizophrenic Patients for up to 28 Days
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
研究概览
简要总结
This study is a placebo-controlled study to assess the safety and tolerability of a novel antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight days. Assessments include blood sampling to determine drug concentrations, psychiatric assessments while under treatment, and movement assessments to evaluate potential side effects.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have schizophrenia that has been stable for at least three months.
- •Willing to discontinue current anti-psychotic medications (under supervision) prior to the study.
- •Willing to live at the study center for a total of 38 days and then return for three follow-up visits.
排除标准
- •Taking medications for conditions other than schizophrenia.
- •History of alcohol or drug abuse within six months of the study, and their alcohol consumption must meet moderate guidelines.
结局指标
主要结局
Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
次要结局
- Assessment of (1) changes in testing scores on a range of psychiatric assessments (PANSS, BPRS. CGI) (2) psychometric performance and (3)body weight/ girth measurement /glucose and lipd measurement, each as a function of duration of dosing.
研究者
相似试验
已完成
1 期
Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy VolunteersHealthyNCT00941018Resolvyx Pharmaceuticals, Inc56
尚未招募
1 期
Phase 1a Study in Healthy ParticipantsHealthyNCT05953506Jiangsu Hansoh Pharmaceutical Co., Ltd.52
终止
1 期
Study to Evaluate the Preliminary Safety, Efficacy, PK and PD of Bryostatin 1 in Patients With Alzheimer's DiseaseAlzheimer's DiseaseNCT02221947Neurotrope Bioscience, Inc.9
终止
1 期
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis PatientsCystic FibrosisNCT02190604Novartis Pharmaceuticals153
已完成
2 期
A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart FailureHeart FailureNCT01120210Johnson & Johnson Pharmaceutical Research & Development, L.L.C.62