Safety, Tolerability and Pharmacokinetics of MK0873 (MK-0873-020) - Full Text View

Purpose

This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK0873 by patch and cream formulation in healthy subjects and psoriasis patients. Part I and Part II in healthy subjects will be initiated prior to Part III in psoriasis patients.

Condition	Intervention	Phase
Plaque Psoriasis	Drug: MK0873 Drug: Comparator: Placebo Cream Drug: Comparator: Placebo/ Plain Patch Drug: Comparator: MK0873 0.5% Cream Drug: Comparator: MK0873 2% Cream Once Daily Drug: Comparator: MK0873 2% Cream Twice Daily	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 3-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK0873 Following Cumulative Patch and Repeated Max Area Applications in Healthy Subjects and Psoriasis Patients

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Incidence of erythema and other local cutaneous irritation [ Time Frame: Day 10 and Day 22 ] [ Designated as safety issue: Yes ]
Local and systemic safety and tolerability of MK0873 cream formulation measured by number of clinical and laboratory adverse experiences [ Time Frame: Through Day 31 ] [ Designated as safety issue: Yes ]
Maximum MK0873 concentration in plasma (Cmax) following topical administration for 10 days [ Time Frame: Day 1 and Day 11 ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	May 2010
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part I - Panel A - MK0873 Patches Healthy subjects will be repeatedly administered skin patches containing various potencies of MK0873 in cream formulation and plain patches	Drug: MK0873 [Intervention Name:MK0873 Patch] Administration of skin patch containing 0.05. 0.5, or 2% MK0873 in cream formulation, a new patch will be applied daily for a total of 21 days
Placebo Comparator: Part I - Panel A - Placebo Patches Healthy subjects will be repeatedly administered skin patches that contain placebo cream and plain patches	Drug: Comparator: Placebo/ Plain Patch Administration of skin patch containing placebo cream or no cream (plain patch), a new patch will be applied daily for 21 days
Experimental: Part II - Panel B - MK0873 Cream or Placebo Healthy Subjects will be administered 5 grams of 0.5% cream twice daily or placebo	Drug: Comparator: Placebo Cream repeated administration of placebo cream by direct application to the skin for 10 days (once or twice daily depending on panel) Drug: Comparator: MK0873 0.5% Cream up to 5 grams of 0.5% MK0873 cream will be applied directly twice daily for 10 days
Experimental: Part II - Panel C - MK0873 Cream or Placebo Healthy Subjects will be administered 5 grams of 2% cream once daily or placebo	Drug: Comparator: Placebo Cream repeated administration of placebo cream by direct application to the skin for 10 days (once or twice daily depending on panel) Drug: Comparator: MK0873 2% Cream Once Daily up to 5 grams of 2% MK0873 cream will be applied directly to 10% of the body area once daily for 10 days
Experimental: Part II - Panel D - MK0873 Cream or Placebo Healthy Subjects will be administered 5 grams of 2% cream twice daily or placebo	Drug: Comparator: Placebo Cream repeated administration of placebo cream by direct application to the skin for 10 days (once or twice daily depending on panel) Drug: Comparator: MK0873 2% Cream Twice Daily up to 5 grams of 2% MK0873 cream will be applied directly twice daily for 10 days
Experimental: Part III - Panel E - MK0873 Cream or Placebo Psoriasis patients will be administered 0.5 grams of 2% cream or placebo	Drug: Comparator: Placebo Cream repeated administration of placebo cream by direct application to the skin for 10 days (once or twice daily depending on panel) Drug: Comparator: MK0873 2% Cream Once Daily up to 5 grams of 2% MK0873 cream will be applied directly to 10% of the body area once daily for 10 days
Experimental: Part III Extension - Panel E - MK0873 Cream or Placebo Psoriasis patients will be administered 0.5 grams of 2% cream or placebo	Drug: Comparator: MK0873 2% Cream Twice Daily up to 5 grams of 2% MK0873 cream will be applied directly to 10% of the body area daily for ~18 days in psoriasis patients

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Part I, II and III:

Female subjects of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
Subject is in good general health
Subject is a nonsmoker

Part III only:

Subject 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:

Subject has a history of stroke, chronic seizures or major neurological disease
Subject has a history of cancer
Subject is a nursing mother

Part III only:

Subject has nonplaque forms of psoriasis
Subject has current drug induced psoriasis
Subject has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis
Subject has used any systemic immunosuppressants or biologics within the past 4 weeks

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01140061 History of Changes
Other Study ID Numbers:	2010_540, MK0873-020
Study First Received:	June 7, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013