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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01140061
First Posted: June 9, 2010
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Plaque Psoriasis Drug: MK-0873 Patch Drug: MK-0873 Cream Drug: Placebo Patch Drug: Placebo Cream Drug: Plain patch Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 3-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK-0873 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:
  • Number of Participants With an Adverse Event of Erythema in Part I of the Study [ Time Frame: Up to Day 22 in Part 1 ]
    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.

  • Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days [ Time Frame: Day 11 ]
    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

  • Number of Participants With an Adverse Event [ Time Frame: Up to 14 days after last dose of study drug (up to Day 42) ]
    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.

  • Number of Participants Who Discontinued Study Medication Due to an Adverse Event [ Time Frame: Up to Day 28 ]
    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.


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: 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.
Drug: MK-0873 Patch
MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873
Drug: Placebo Patch
Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
Drug: Plain patch
Plain patch containing no MK-0873 or placebo
Placebo Comparator: Panel A - Placebo
In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
Drug: Placebo Patch
Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
Drug: Plain patch
Plain patch containing no MK-0873 or placebo
Experimental: 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.
Drug: MK-0873 Cream
MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
Placebo Comparator: Panel B - Placebo
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Drug: Placebo Cream
Placebo cream matching MK-0873 0.05%, 0.5%, or 2%
Experimental: 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.
Drug: MK-0873 Cream
MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
Placebo Comparator: Panel C - Placebo
In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
Drug: Placebo Cream
Placebo cream matching MK-0873 0.05%, 0.5%, or 2%
Experimental: 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.
Drug: MK-0873 Cream
MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
Placebo Comparator: Panel D - Placebo
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Drug: Placebo Cream
Placebo cream matching MK-0873 0.05%, 0.5%, or 2%
Experimental: 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.
Drug: MK-0873 Cream
MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
Placebo Comparator: 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.
Drug: Placebo Cream
Placebo cream matching MK-0873 0.05%, 0.5%, or 2%

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140061


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01140061     History of Changes
Other Study ID Numbers: 0873-020
First Submitted: June 7, 2010
First Posted: June 9, 2010
Results First Submitted: October 29, 2014
Results First Posted: December 12, 2014
Last Update Posted: April 7, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
MK 0873
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action