NL-OMON32622已完成不适用
A Phase I, open-label, single-sequence drug-drug interaction trial in subjects on stable methadone maintenance therapy, to investigate the potential interaction between TMC278 25 mg q.d. and methadone, at steady-state. - Trial to investigate the interaction between TMC278 and methadone.
TIBOTEC PHARMACEUTICALS LIMITED, EASTGATE VILLAGE, EASTGATE, LITTLE ISLAND, CO. CORK, IRELAND, In Nederland vertegenwoordigd door Janssen-Cilag B.V. afdeling GCO0 个研究点目标入组 16 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
- 16
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. Male or female, aged between 18 and 55 years, extremes included;
- •2. Body Mass Index of 18.0 to 35.0 kg/m2, extremes included;
- •3. Informed Consent Form signed voluntarily before first trial-related activity;
- •4. Receiving once daily oral methadone maintenance therapy at a stable individualized dose;
- •5. The subject agrees:
- •- not to change the current methadone dose from screening until Day 11 included;
- •- to have a daily observed and documented methadone intake from Day *14 until Day 12, and a daily observed and documented TMC278 intake from Day 1 until Day 11;
- •6. Able to comply with protocol requirements;
- •7. The subject has obtained approval from his/her addiction physician for the subject*s participation in this trial. Furthermore, the addiction physician agrees to provide medical care for the subject after discharge from trial center;
- •8. General medical condition, in the investigator*s opinion, does not interfere with the assessments and the completion of the trial;
- •9. Otherwise healthy on the basis of screening
排除标准
- •1. A positive HIV 1 or HIV 2 test at trial screening.
- •2. Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post surgical sterilization (without reversal operation).
- •3. Evidence of current use of barbiturate, amphetamine, recreational drugs or opioids, with the exception of methadone.
- •4. Current use of alcohol, which in the investigator*s opinion would compromise subject*s safety and/or compliance with the trial procedures.
- •5. Hepatitis A infection at screening.
- •6. Decompensated liver function
- •7. Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric (other than drug dependency), metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease.
- •8. Significant heart abnormalities.
- •9. Current or history of adrenal disorder.
- •10. Currently significant diarrhea, gastric stasis, or constipation (other than the pharmacodynamic effects of methadone) that in the investigator*s opinion could influence drug absorption or bioavailability.
- •11. 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.
- •12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial (i.e. TMC278).
- •13. Previous experience of clinically significant hypersensitivity to methadone hydrochloride.
- •14. Use of disallowed concomitant therapy during the 14 days prior to the first dose of TMC278. Concomitant therapy that is not disallowed should not be changed between Day -14 and Day 11, except for ibuprofen and paracetamol.
- •15. Having previously participated in more than 1 trial (single or multiple dose) with TMC125, TMC120 and/or TMC278 (formerly known as R278474) or having developed a rash, erythema or urticaria while participating in a trial with the aforementioned compounds.
- •16. Lack of good/reasonable venous access.
- •17. Participation in an investigational drug trial within 60 days prior to Day -14.
- •18. Donation of blood or plasma or significant blood loss within 60 days prior to Day -14.
- •19. Any laboratory abnormalities at screening which could be of influence on the study.
研究者
相似试验
已完成
不适用
A phase 1, open-label, fixed-sequence, drug-drug interaction study of APX001 to evaluate the effects of CYP3A4 inhibition and pan-CYP induction in two parallel groups of healthy male and female subjectsFungal infectionsNL-OMON47992Amplyx Pharmaceuticals, Inc.36
已完成
不适用
A phase 1, open-label, fixed-sequence, drug-drug interaction study between multiple oral doses of Inarigivir Soproxil and a single oral dose of midazolam in healthy subjectsHepatitis BNL-OMON46790Spring Bank Pharmaceuticals, Inc.16
进行中（未招募）
1 期
A study to evaluate the effect of itraconazole and carbamazepine on the processing of fenebrutinib by the body in healthy participantsHealthy volunteersISRCTN12005942Genentech32
已完成
不适用
A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Assess the Effect of Multiple Doses of Oral THB001 on the Pharmacokinetics of Oral Caffeine, Omeprazole, and Midazolam (CYP1A2, CYP2C19 and CYP3A4 probe substrates) in Healthy Volunteersallergic mediated diseasesand food allergychronic idiopathic and inducible urticariaallergic asthmachronic rhinosinusitisNL-OMON51382Third Harmonic Bio18
尚未招募
不适用
A phase I, multi-center, open-label, drug-drug interaction study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on TKI258 (dovitinib) pharmacokinetics in patients with advanced solid tumors.advanced cancersolid tumors10027655NL-OMON39285ovartis12