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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01140061
First received: June 7, 2010
Last updated: June 26, 2012
Last verified: June 2012
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014