EUCTR2011-004159-38-BE进行中（未招募）不适用
A Phase I, open label, randomized, crossover trial in healthy subjects toinvestigate the effect of steady-state TMC278 on the pharmacokinetics ofa single dose of digoxin. - NA
Janssen R&D Ireland0 个研究点开始时间: 2011年11月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men or women between 18 and 55 years of age, extremes included.
- •2. Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device (IUD), diaphragm, cervical cap or hormone based contraceptives by their female partner) when having sexual intercourse with a female partner of childbearing potential, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
- •Men who had a vasectomy and have a female partner of childbearing potential must agree to use a male condom during the study and for 3 months after receiving the last dose of study drug.
- •If the female sexual partner is postmenopausal for at least 2 years or is surgically sterile (has had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant), she is not considered to be of childbearing potential and hence the birth control methods mentioned are not applicable.
- •Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
- •If a subject's partner becomes pregnant in the time between when the subject starts taking the study drug until 1 month after the last dose, the investigator must be informed immediately.
- •3. Women must:
- •- be postmenopausal for at least 2 years, OR
- •- be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of
- •becoming pregnant).
- •4. Women must have a negative pregnancy test at screening.
- •5. Subjects must be non-smoking.
- •6. Subject must have a Body Mass Index (BMI) of 18.5 to 30.0 kg/m2, extremes included
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A positive HIV-1 or HIV-2 test at screening.
- •2. Hepatitis A, B or C infection (confirmed by hepatitis A immunoglobulin (IgM), HBsAg, or hepatitis C virus antibody, respectively) at screening.
- •3. A positive urine drug test at screening or on Day -1 of Treatment A or on Day 1 of Treatment B. Urine will be tested for the presence of amphetamines, barbiturates,
- •benzodiazepines, cocaine, cannabinoids, methadone, and opioids.
- •Note: a positive test may be repeated once to exclude a technical error. Retesting will take place during the same visit. Subjects with a confirmed positive urine drug test at screening or on Day -1 of Treatment A or on Day 1 of Treatment B of Session 1 will be excluded.
- •4. Female subjects should not be breastfeeding.
- •5. Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrine, renal, hepatic, respiratory, inflammatory or infectious disease.
- •6. Currently significant diarrhea or gastric stasis that in the investigator’s opinion could influence drug absorption or bioavailability.
- •7. Less than 2 or 3 bowel movements on average per week.
- •8. Any history of significant skin disease such as but not limited to drug rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria.
- •9. Previously demonstrated clinically significant allergy or hypersensitivity to the drug or any of the excipients of the drug administered in this study (i.e., TMC278, digoxin or digitalis preparations).
- •10. Use of concomitant medication, including over-the-counter (OTC) products, herbal medications, and dietary supplements .
- •11. Having previously participated in more than 1 study (single or multiple dose) with TMC125 (etravirine), TMC120 (dapivirine) and/or TMC278 (rilpivirine hydrochloride, formerly known as R278474) or having developed a rash, erythema or urticaria while participating in a study with the aforementioned compounds.
- •12. Received an investigational product (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment or currently enrolled in an investigational study.
- •13. History of clinically relevant heart rhythm disturbances.
- •14. History of idiopathic hypertrophic subaortic stenosis (IHSS, hypertrophic cardiomyopathy), AV block, ventricular tachycardia/ventricular fibrillation or family history of sudden cardiac death.
- •15. Wolff (Wolfe)-Parkinson-White (WPW) syndrome or any other clinically relevant abnormality on ECG on Day 1 of the first session.
- •NOTE: Investigators should ensure that all study enrollment criteria have been met at screening.
- •If a subject's status changes after screening but before first dose of study drug is given such that they now meet an exclusion criterion, they should be excluded from participation in the study.
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