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

Phase 1

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: MK-0873 Patch; Drug: MK-0873 Cream; Drug: Placebo Cream; Drug: Placebo Patch; Drug: Plain patch

• Registration Number: NCT01140061
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-01
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-09
• Primary Completion: 2011-03-01
• Study Completion: 2011-03-01
• Results First Submitted: 2014-10-29
• Results First Submitted QC: 2014-12-11
• Results First Posted: 2014-12-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Panel A - MK-0873 5.1 mg	MK-0873 Patch	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.
Panel E and Extension - MK-0873 200 mg	MK-0873 Cream	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.
Panel C - MK-0873 100 mg	MK-0873 Cream	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.
Panel D - MK-0873 200 mg	MK-0873 Cream	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.
Panel C - Placebo	Placebo Cream	In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
Panel A - MK-0873 5.1 mg	Placebo Patch	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.
Panel A - MK-0873 5.1 mg	Plain patch	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.
Panel A - Placebo	Placebo Patch	In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
Panel A - Placebo	Plain patch	In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
Panel E and Extension - Placebo	Placebo Cream	In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
Panel B - MK-0873 25 mg	MK-0873 Cream	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.
Panel B - Placebo	Placebo Cream	In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Panel D - Placebo	Placebo Cream	In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Adverse Event of Erythema in Part I of the Study	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.
Number of Participants With an Adverse Event	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.
Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days	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 Who Discontinued Study Medication Due to an Adverse Event	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.