NL-OMON32571已完成不适用
A Phase I, open-label trial to investigate the pharmacokinetic interaction between TMC125 and two antifungal agents (fluconazole and voriconazole), all at steady-state in healthy subjects. - Phase 1 open-label trial with TMC125.
Tibotec Pharmaceuticals Ltd, 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 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Aged between 18 and 55 years, extremes included.
- •2. Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to screening.
- •3. Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included.
- •4. Informed Consent Forms signed voluntarily before first trial-related activity.
- •5. Able to comply with protocol requirements.
- •6. Healthy on the basis of medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including skin examination), medical and surgical history, electrocardiogram (ECG), vital signs and the results of blood biochemistry, hematology and a urinalysis carried out at screening.
排除标准
- •1. A positive HIV-1 or HIV-2 result at study screening.
- •2. Females who are not postmenopausal since more than two years, or not had a post-hysterectomy or are not surgically sterilized (without reversal operation).
- •3. History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use which in the investigator's opinion would compromise subject's safety and/or compliance with study procedures.
- •4. A positive Hepatitis A, B or C result at study screening.
- •5. A positive urine drug test at study screening or on Day -1 of each session.
- •6. Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease.
- •7. Currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
- •8. Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria.
- •9. Previously demonstrated clinically significant allergy or hypersensitivity to fluconazole, voriconazole and/or any of the excipients of the investigational medication administered on this trial.
- •10. A history of heart disease.
- •11. Clinically relevant heart rhythm disturbances.
- •12. High bloodpressure.
- •13. History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- •14. Use of concomitant medication, including over-the-counter products and dietary supplements. Systemic over-the-counter medication must have been discontinued at least 7 days prior to the first dose of study medication; prescribed medication and all products containing Hypericum Perforatum must have been discontinued at least 14 days before the first dose of study medication, except for paracetamol.
- •15. Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.
- •16. Donation of blood plasma within the 60 days preceding the first intake of trial medication.
- •17. Having participated in more than 1 trial (single or multiple dose) with TMC125 (etravine), TMC120 (dapirivine) and/or TMC278 (rilpivirine, formerly known as R278474) or having developed rash, erythema or urticaria while participating in a trial with the aforementioned compounds.
- •18. Subjects with laboratory abnormalities.
研究者
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