Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
January 17, 2019 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
MK-0873 skin patches containing 0.05%.
0.5%, or 2% MK-0873
Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
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.
|
Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Placebo cream matching MK-0873 0.05%, 0.5%, or 2%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to Day 22 in Part 1
|
|
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
|
Day 11
|
|
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.
|
Up to 14 days after last dose of study drug (up to Day 42)
|
|
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.
|
Up to Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
June 7, 2010
First Submitted That Met QC Criteria
June 7, 2010
First Posted (Estimate)
June 9, 2010
Study Record Updates
Last Update Posted (Actual)
February 8, 2019
Last Update Submitted That Met QC Criteria
January 17, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0873-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.