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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo Patch; Drug: MK-0873 Patch; Drug: Plain patch; Drug: Placebo Cream; Drug: MK-0873 Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01140061

0873-020

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 10 patient groups, including a placebo group

Panel A - MK-0873 5.1 mg

Experimental group

Description:

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.

Treatment:

Drug: Plain patch

Drug: Placebo Patch

Drug: MK-0873 Patch

Panel A - Placebo

Placebo Comparator group

Description:

In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.

Treatment:

Drug: Plain patch

Drug: Placebo Patch

Panel B - MK-0873 25 mg

Experimental group

Description:

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.

Treatment:

Drug: MK-0873 Cream

Panel B - Placebo

Placebo Comparator group

Description:

In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.

Treatment:

Drug: Placebo Cream

Panel C - MK-0873 100 mg

Experimental group

Description:

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.

Treatment:

Drug: MK-0873 Cream

Panel C - Placebo

Placebo Comparator group

Description:

In Part II, healthy participants received skin application of placebo cream once daily for 10 days.

Treatment:

Drug: Placebo Cream

Panel D - MK-0873 200 mg

Experimental group

Description:

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.

Treatment:

Drug: MK-0873 Cream

Panel D - Placebo

Placebo Comparator group

Description:

In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.

Treatment:

Drug: Placebo Cream

Panel E and Extension - MK-0873 200 mg

Experimental group

Description:

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.

Treatment:

Drug: MK-0873 Cream

Panel E and Extension - Placebo

Placebo Comparator group

Description:

In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.

Treatment:

Drug: Placebo Cream