NCT00692250已完成1 期
A Phase I Open Label, Randomised, Single Dose, 2-way Crossover, 2-Sequence Pharmacokinetic Study on the Interaction of Colesevelam and Ciclosporin in Healthy Volunteers
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))
研究概览
简要总结
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Subject must have a body mass index (BMI) between 19 and 25 inclusive
- •Medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ECGs.
- •Give voluntary written informed consent to participate in the study
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic, gastrointestinal (inclusive of dysphagia, swallowing disorders, severe gastrointestinal motility disorders), endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease.
- •In addition, history or presence of: Alcoholism or drug abuse within the past year; OR hypersensitivity or idiosyncratic reaction to ciclosporin or other immunosuppressive agents; OR Chronic infection
- •Subjects who ere tested positive at screening for HIV, HBsAg or HCV
- •Subjects who received injectable corticosteroids in the 12 weeks preceding the first dose.
- •Subjects who are allergic to castor oil or corn oil
- •Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing
- •Subjects who have used any medications or substances known to be strong inhibitors of CYP3A enzymes within 10 days prior to the first dose.
- •Subjects who have used any medications or substances known to be strong inducers of CYP3A enzymes within 28 days prior to the first dose.
- •Subjects who have used antibiotics within 14 days prior to the first dose.
- •Subjects who have used other medication (including over-the-counter products) vitamins and herbal products within 7 days prior to the first dose.
- •Subjects who have used any live attenuated vaccine within 7 days prior to the first dose or are planning to use within 14 days after the end of the study.
- •Subjects who, prior to informed consent, would have donated in excess of: 500mL of blood in 14 days;1500mL of blood in 180 days; OR 2500mL of blood in 1 year.
- •Subjects who have participated in another clinical trial: within a period less or equal to 2 half live (t1/2) of the previous investigational product used OR within 60 days prior to first dose.
结局指标
主要结局
Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))
时间窗: 12 weeks
次要结局
- Safety(12)
- Tolerability(12 Weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and RifampinDrug Interaction PotentiationNCT03801746Akebia Therapeutics40
已完成
2 期
Copenhagen Head Injury Ciclosporin (CHIC) StudyTraumatic Brain InjuryNCT01825044NeuroVive Pharmaceutical AB16
已完成
4 期
Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving SirolimusKidney TransplantationNCT00507793Wyeth is now a wholly owned subsidiary of Pfizer385
已完成
3 期
Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)Impaired Fasting GlucosePrediabetesNCT00990184Seattle Institute for Biomedical and Clinical Research21
已完成
1 期
Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy SubjectsPurpura, Thrombocytopenic, IdiopathicNCT02281370GlaxoSmithKline39