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NCT Number: NCT01140061

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-0873 Patch

Drug

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

MK-0873 Cream

Drug

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

Placebo Patch

Drug

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

placebo cream

Drug

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

Plain patch

Drug

Plain patch containing no MK-0873 or placebo

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2010
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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