Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: MK-0873 Patch
* Drug: MK-0873 Cream
* Drug: Placebo Patch
* Drug: Placebo Cream
* Drug: Plain patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panel A - MK-0873 5.1 mg<br>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. | Drug: MK-0873 Patch<br>* MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873<br>Drug: Placebo Patch<br>* Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches<br>Drug: Plain patch<br>* Plain patch containing no MK-0873 or placebo<br>|
| Placebo Comparator: Panel A - Placebo<br>In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days. | Drug: Placebo Patch<br>* Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches<br>Drug: Plain patch<br>* Plain patch containing no MK-0873 or placebo<br>|
| Experimental: Panel B - MK-0873 25 mg<br>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. | Drug: MK-0873 Cream<br>* MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873<br>|
| Placebo Comparator: Panel B - Placebo<br>In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. | Drug: Placebo Cream<br>* Placebo cream matching MK-0873 0.05%, 0.5%, or 2%<br>|
| Experimental: Panel C - MK-0873 100 mg<br>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. | Drug: MK-0873 Cream<br>* MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873<br>|
| Placebo Comparator: Panel C - Placebo<br>In Part II, healthy participants received skin application of placebo cream once daily for 10 days. | Drug: Placebo Cream<br>* Placebo cream matching MK-0873 0.05%, 0.5%, or 2%<br>|
| Experimental: Panel D - MK-0873 200 mg<br>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. | Drug: MK-0873 Cream<br>* MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873<br>|
| Placebo Comparator: Panel D - Placebo<br>In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. | Drug: Placebo Cream<br>* Placebo cream matching MK-0873 0.05%, 0.5%, or 2%<br>|
| Experimental: Panel E and Extension - MK-0873 200 mg<br>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. | Drug: MK-0873 Cream<br>* MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873<br>|
| Placebo Comparator: Panel E and Extension - Placebo<br>In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days. | Drug: Placebo Cream<br>* Placebo cream matching MK-0873 0.05%, 0.5%, or 2%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Adverse Event of Erythema in Part I of the Study | 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. | Up to Day 22 in Part 1 | 
| Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days | 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 | Day 11 | 
| Number of Participants With an Adverse Event | 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. | Up to 14 days after last dose of study drug (up to Day 42) | 
| Number of Participants Who Discontinued Study Medication Due to an Adverse Event | 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. | Up to Day 28 |