NL-OMON46290已完成不适用
An open-label, multi-centre drug-drug interaction trial to investigate the effects of tralokinumab on the pharmacokinetics of selected cytochrome P450 (CYP) substrates in adult subjects with moderate-to-severe atopic dermatitis - Drug-drug interaction tralokinumab in moderate-to-severe atopic dermatitis
eo Pharma0 个研究点目标入组 10 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
- 10
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 64（—）
入选标准
- •* Age 18 and above.
- •* Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
- •* History of AD for *1 year.
- •* Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
- •* AD involvement of *10% body surface area at screening and baseline.
- •* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
- •* Willingness to abstain from consumption of any 1 or more of the following items in the periods specified:
- •o ±7 days within each cocktail dosing visit (that is, between the Day -14 and Day 15 visits and between the Week 14 and Week 16 visits): foods/beverages that affect the CYP system:
- •- Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
- •- Cruciferous vegetables, including but not limited to broccoli, cabbage, cauliflower, kale, Brussels sprout, radish, turnip, horseradish.
- •- Chargrilled meat.
- •o ±48 hours within each cocktail dosing visit: caffeinated beverages, foods/drugs that contain caffeine, including coffee, tea (black and green), coca cola, energy drinks, and chocolate.
排除标准
- •* Administration, within 14 days or 5 half-lives (whichever is longer) prior to Day -7, of any medication that is a known inducer or inhibitor of 1 or more of the following CYP enzymes: CYP3A, CYP2C19, CYP2C9, CYD2D6, and CYP1A2.
- •* Subjects who are poor metabolisers of CYP2C9, CYP2C19, or CYP2D6, based on genotyping.
- •* Any contraindication to 1 or more of the following drugs, according to the applicable labelling: caffeine, warfarin, omeprazole, metoprolol, or midazolam.
- •* Consumption of any 1 or more of the following items in the periods specified:
- •o From Day -14 (±7 days within each cocktail dosing visit):
- •foods/beverages that affect the CYP system:
- •- Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
- •- Cruciferous vegetables, including but not limited to broccoli, cabbage, cauliflower, kale, Brussels sprout, radish, turnip, horseradish.
- •- Chargrilled meat.
- •o From Day -9 (±48 hours within each cocktail dosing visit):
- •caffeinated beverages, foods/drugs that contain caffeine, including coffee, tea (black and green), coca cola, energy drinks, and chocolate.
- •* Nausea or diarrhoea 1 week prior to Day -7.
- •* Active dermatologic conditions that may confound the diagnosis of AD.
- •* Use of tanning beds or phototherapy within 5 weeks prior to Day -7.
- •* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 3 weeks prior to Day -7.
- •* Treatment with topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase 4 inhibitors within 1 week prior to Day -7.
- •* Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational biologic agents:
- •o Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline (Day -7), or until lymphocyte count returns to normal, whichever is longer.
- •o Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline (Day -7).
- •* Active skin infection within 1 week prior to Day -7.
- •* Clinically significant infection within 4 weeks prior to Day -7.
- •* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- •* Tuberculosis requiring treatment within the 12 months prior to screening.
- •* Known primary immunodeficiency disorder.
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