A 3-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK-0873 Following Cumulative Patch and Repeated Max Area Applications in Healthy Subjects and Psoriasis Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Number of Participants With an Adverse Event of Erythema in Part I of the Study
研究概览
简要总结
This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK-0873 by patch or cream formulation in healthy participants and participants with mild psoriasis. Part I and Part II in healthy participants will be initiated prior to Part III in psoriasis participants. The primary hypotheses of the study are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with psoriasis and 2) that the maximum plasma concentration of MK-0873 is <20 nM in healthy participants and participants with psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part I, II and III:
- •Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control;
- •In good general health;
- •Nonsmoker;
- •Part III only:
- •Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;
排除标准
- •Part I, II and III:
- •Has a history of stroke, chronic seizures or major neurological disease;
- •Has a history of cancer;
- •Is a nursing mother;
- •Part III only:
- •Has nonplaque forms of psoriasis;
- •Has current drug-induced psoriasis;
- •Has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis;
- •Has used any systemic immunosuppressants or biologics within the past 4 weeks.
研究组 & 干预措施
Panel A - MK-0873 5.1 mg
In Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days.
干预措施: MK-0873 Patch (Drug)
Panel A - MK-0873 5.1 mg
In Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days.
干预措施: Placebo Patch (Drug)
Panel A - MK-0873 5.1 mg
In Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days.
干预措施: Plain patch (Drug)
Panel A - Placebo
In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
干预措施: Placebo Patch (Drug)
Panel A - Placebo
In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
干预措施: Plain patch (Drug)
Panel B - MK-0873 25 mg
In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK- 0873) twice daily for 10 days.
干预措施: MK-0873 Cream (Drug)
Panel B - Placebo
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
干预措施: Placebo Cream (Drug)
Panel C - MK-0873 100 mg
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
干预措施: MK-0873 Cream (Drug)
Panel C - Placebo
In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
干预措施: Placebo Cream (Drug)
Panel D - MK-0873 200 mg
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
干预措施: MK-0873 Cream (Drug)
Panel D - Placebo
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
干预措施: Placebo Cream (Drug)
Panel E and Extension - MK-0873 200 mg
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
干预措施: MK-0873 Cream (Drug)
Panel E and Extension - Placebo
In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
干预措施: Placebo Cream (Drug)
结局指标
主要结局
Number of Participants With an Adverse Event of Erythema in Part I of the Study
时间窗: Up to Day 22 in Part 1
Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Number of Participants With an Adverse Event
时间窗: Up to 14 days after last dose of study drug (up to Day 42)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days
时间窗: Day 11
Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis
Number of Participants Who Discontinued Study Medication Due to an Adverse Event
时间窗: Up to Day 28
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
次要结局
未报告次要终点