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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140061
• Other study ID #: 0873-020
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2010
• Est. completion date: March 1, 2011

Study information

• Verified date: January 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 1, 2011
• Est. primary completion date: March 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• MK-0873 Patch
MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873
• MK-0873 Cream
MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
• Placebo Patch
Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
• Placebo Cream
Placebo cream matching MK-0873 0.05%, 0.5%, or 2%
• Plain patch
Plain patch containing no MK-0873 or placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Adverse Event of Erythema in Part I of the Study	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.	Up to Day 22 in Part 1
Primary	Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days	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	Day 11
Primary	Number of Participants With an Adverse Event	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.	Up to 14 days after last dose of study drug (up to Day 42)
Primary	Number of Participants Who Discontinued Study Medication Due to an Adverse Event	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.	Up to Day 28