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

Merck Sharp & Dohme LLC42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Plaque Psoriasis

Interventions

MK-0873 Patch

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: Up to Day 28