ACTRN12615000511538已完成1 期
A Two-Part Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Immediate and Delayed Release Formulations of CTP-730 in Healthy Volunteers.
CPR Pharma Services0 个研究点目标入组 22 人开始时间: 2015年5月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1. Healthy adult males and females between 18 and 50 years of age.
- •2. Body weight >/= 50 kg and BMI within the range of 18 to 30 kg/m2.
排除标准
- •1. Medical, psychiatric illness or history of depression that could, in the investigator’s opinion, compromise the
- •subject’s safety.
- •2. Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject
- •from participating in the study.
- •3. History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal,
- •hepatic, or gastrointestinal (GI) conditions.
- •4. PR interval >/= 220 msec or QRS duration >/= 120 msec or QTcB / QTcF interval > 450 msec obtained at
- •screening visit or prior to the first dose of study drug.
- •5. Liver function tests greater than the upper limit of normal.
- •6. Positive screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or
- •hepatitis C virus antibody at screening.
- •7. Urinalysis positive for protein or glucose.
- •8. A positive screen for alcohol, drugs of abuse, or tobacco use.
- •9. Inability to comply with food and beverage restrictions during study participation.
- •10. Donation or blood collection or acute loss of blood prior to screening.
研究者
相似试验
进行中（未招募）
1 期
A Two-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, and Effects on Histology and Different Clinical Parameters of Givinostat in Ambulant Children with Duchenne Muscular DystrophyMedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersDuchenne Muscular DystrophyEUCTR2012-002566-12-ITITALFARMACO20
已完成
2 期
A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 3: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants wearing four prototype skin patches.ISRCTN16859029Defence Science and Technology Laboratory (Dstl)24
进行中（未招募）
1 期
A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat in Combination With Nivolumab in Select Advanced CancersEUCTR2016-002423-29-GBincyte Corporation291
进行中（未招募）
1 期
A Study to Test if TV-46000 is Safe for Maintenance Treatment of SchizophreniaMaintenance treatment of schizophrenia in patients currently treated with oral antipsychoticsMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2019-000063-24-FRTeva Branded Pharmaceutical Products R&D, Inc.300
已完成
不适用
A Study to Evaluate the Safety, Tolerability, and Effects on NSAID-Induced Small Bowel Pathology of K-196 in Healthy Volunteers.Inflammatory bowel disease (IBD)10017969NL-OMON51579Kallyope, Inc.70