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

NCT ID: NCT01140061

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-01
• Study Completion Date: 2011-03-01

Brief Summary

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

MK-0873 Patch

Intervention Type: DRUG

MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873

Placebo Patch

Intervention Type: DRUG

Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches

Plain patch

Intervention Type: DRUG

Plain patch containing no MK-0873 or placebo

Panel A - Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo Patch

Intervention Type: DRUG

Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches

Plain patch

Intervention Type: DRUG

Plain patch containing no MK-0873 or placebo

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.

Group Type: EXPERIMENTAL

MK-0873 Cream

Intervention Type: DRUG

MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873

Panel B - Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo Cream

Intervention Type: DRUG

Placebo cream matching MK-0873 0.05%, 0.5%, or 2%

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.

Group Type: EXPERIMENTAL

MK-0873 Cream

Intervention Type: DRUG

MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873

Panel C - Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo Cream

Intervention Type: DRUG

Placebo cream matching MK-0873 0.05%, 0.5%, or 2%

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.

Group Type: EXPERIMENTAL

MK-0873 Cream

Intervention Type: DRUG

MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873

Panel D - Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo Cream

Intervention Type: DRUG

Placebo cream matching MK-0873 0.05%, 0.5%, or 2%

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.

Group Type: EXPERIMENTAL

MK-0873 Cream

Intervention Type: DRUG

MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873

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.

Group Type: PLACEBO_COMPARATOR

Placebo Cream

Intervention Type: DRUG

Placebo cream matching MK-0873 0.05%, 0.5%, or 2%

Interventions

MK-0873 Patch

MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873

Intervention Type: DRUG

MK-0873 Cream

MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873

Intervention Type: DRUG

Placebo Patch

Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches

Intervention Type: DRUG

Placebo Cream

Placebo cream matching MK-0873 0.05%, 0.5%, or 2%

Intervention Type: DRUG

Plain patch

Plain patch containing no MK-0873 or placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0873-020

Identifier Type: -

Identifier Source: org_study_id