Back to resultsSafety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-0873 Patch
MK-0873 Cream
Placebo Patch
Placebo Cream
Plain patch
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Panel A - MK-0873 5.1 mg
Panel A - Placebo
Panel B - MK-0873 25 mg
Panel B - Placebo
Panel C - MK-0873 100 mg
Panel C - Placebo
Panel D - MK-0873 200 mg
Panel D - Placebo
Panel E and Extension - MK-0873 200 mg
Panel E and Extension - Placebo
Arm Description
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.
In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
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.
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
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.
In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
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.
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
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.
In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
Outcomes
Primary Outcome Measures
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.
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
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01140061
Brief Title
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
March 1, 2011 (Actual)
Study Completion Date
March 1, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Panel A - MK-0873 5.1 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Panel A - Placebo
Arm Type
Placebo Comparator
Arm Description
In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
Arm Title
Panel B - MK-0873 25 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Panel B - Placebo
Arm Type
Placebo Comparator
Arm Description
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Arm Title
Panel C - MK-0873 100 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Panel C - Placebo
Arm Type
Placebo Comparator
Arm Description
In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
Arm Title
Panel D - MK-0873 200 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Panel D - Placebo
Arm Type
Placebo Comparator
Arm Description
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Arm Title
Panel E and Extension - MK-0873 200 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Panel E and Extension - Placebo
Arm Type
Placebo Comparator
Arm Description
In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
Intervention Type
Drug
Intervention Name(s)
MK-0873 Patch
Intervention Description
MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873
Intervention Type
Drug
Intervention Name(s)
MK-0873 Cream
Intervention Description
MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
Intervention Type
Drug
Intervention Name(s)
Placebo Patch
Intervention Description
Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
Intervention Type
Drug
Intervention Name(s)
Placebo Cream
Intervention Description
Placebo cream matching MK-0873 0.05%, 0.5%, or 2%
Intervention Type
Drug
Intervention Name(s)
Plain patch
Intervention Description
Plain patch containing no MK-0873 or placebo
Primary Outcome Measure Information:
Title
Number of Participants With an Adverse Event of Erythema in Part I of the Study
Description
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.
Time Frame
Up to Day 22 in Part 1
Title
Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days
Description
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
Time Frame
Day 11
Title
Number of Participants With an Adverse Event
Description
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.
Time Frame
Up to 14 days after last dose of study drug (up to Day 42)
Title
Number of Participants Who Discontinued Study Medication Due to an Adverse Event
Description
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.
Time Frame
Up to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=0873-020&kw=0873-020&tab=access
Learn more about this trial
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
We'll reach out to this number within 24 hrs