NL-OMON33802已完成不适用
Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911. - Phase I trial to examine TMC558445 and TMC310911.
Tibotec Pharmaceuticals, EastGate Village, Eastgate, Little Island, CO Cork, Ireland, In Nederland vertegenwoordigd door Janssen-Cilag B.V.0 个研究点目标入组 54 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) 18-60 years;
- •2) Nonsmoker;
- •3) BMI 18.0-30.0;
- •4) Signed ICF
- •5) Able to comply with protocol requirements
- •6) Healthy based on the basis of a medical evaluation.
排除标准
- •1) History of clinically significant heart arrhythmias;
- •2) Female except if they are of non-childbearing potential;
- •3) History or evidence of alcohol and or drug abuse ;
- •4) Hepatitis A, B en C;
- •5) Positive urine drug test;
- •6) Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease;
- •7) Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria
- •8) History of drug allergy;
- •9) Use of concomitant medication, except for paracetamol and ibuprofen in the 14 before first trial medication intake;
- •10) Participation in an investigational drug trial within 60 days prior to the first intake of trial medication;
- •11) Donation of blood plasma within the 60 days preceding the first intake of trial medication;
- •12) Lab abnormalities.
研究者
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