NL-OMON33338已完成不适用
Phase I, double-blind, randomized, placebo-controlled trial in healthy volunteers to examine the safety, tolerability and plasma pharmacokinetics of TMC589337 and TMC589354 after increasing single oral doses and in an open-label part after different repeated oral doses in combination with a single oral dose of TMC310911. - A Phase I trial with TMC589337, TMC589354 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 46 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
- 46
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. Subjects aged between 18 and 55 years, extremes included.
- •2. Non smokers for at least 3 months prior to selection.
- •3. Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included.
- •4. Informed consent signed voluntarily.
- •5. Able to comply with protocol requirements.
- •6. Healthy on basis of a pre-trial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs and an ECG.
排除标准
- •1. Past history of significant heart arrhythmias.
- •2. Female, except if postmenopausal for more than 2 years, or posthysterectomy or post-surgical sterilization (without reversal operation).
- •3. History of alcohol or drug abuse.
- •4. Hepatitis A, B or C infection of HIV-1 or HIV-2 infection at trial screening.
- •5. A positive urine drug test at screening.
- •6. Currently active clinically relevant or significant underlying gastro-intestinal-, cardiovascular-, nervous system-, psychiatric-, metabolic-, renal-, hepatic-, respiratory-, inflammatory-, or infectious disease.
- •7. History of clinically relevent skin disease such as but not limited to dermatitis, eczema, drug allergy, psoriasis, food allergy, urticaria.
- •8. History of drug allergy such as but not limited to sulfonamides and penicillins or drug allergy witnessed in previous trials with experimental drugs.
- •9. Use of concomitant medication, except for paracetamol (acetaminophen) and ibuprofen in a period of 14 days before the first trial medication intake.
- •10. Participation in an investigational drug trial within 90 days (after last intake) prior to the first intake of trial medication.
- •11. Donation of blood or plasma in the 60 days preceding the first intake if trial medication.
- •12. Subjects with lababnormalities at screening.
研究者
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