Plaque PsoriasisPhase 1NCT01140061

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

A Phase 1 study testing MK-0873 Patch, MK-0873 Cream and Plain patch in people with Plaque Psoriasis, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Plaque Psoriasis
What is being tested?: MK-0873 Patch, MK-0873 Cream and Plain patch
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: No sites listed yet
Study dates: 1 May 2010to 1 Mar 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

Show all 9Show fewer

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.

About this study

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

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.

Conditions: Plaque Psoriasis
Being tested: MK-0873 Patch, MK-0873 Cream, Placebo Patch, Placebo Cream, Plain patch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-0873 PatchDrug
MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873
MK-0873 CreamDrug
MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
Placebo PatchDrug
Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
Placebo CreamDrug
Placebo cream matching MK-0873 0.05%, 0.5%, or 2%
Plain patchDrug
Plain patch containing no MK-0873 or placebo

Study groups in NCT01140061
Study group	Role	What they receive
Panel A - MK-0873 5.1 mg	Experimental	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. Receives: Drug: MK-0873 Patch; Drug: Placebo Patch; Drug: Plain patch
Panel A - Placebo	Placebo comparator	In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days. Receives: Drug: Placebo Patch; Drug: Plain patch
Panel B - MK-0873 25 mg	Experimental	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. Receives: Drug: MK-0873 Cream
Panel B - Placebo	Placebo comparator	In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. Receives: Drug: Placebo Cream
Panel C - MK-0873 100 mg	Experimental	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. Receives: Drug: MK-0873 Cream
Panel C - Placebo	Placebo comparator	In Part II, healthy participants received skin application of placebo cream once daily for 10 days. Receives: Drug: Placebo Cream
Panel D - MK-0873 200 mg	Experimental	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. Receives: Drug: MK-0873 Cream
Panel D - Placebo	Placebo comparator	In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. Receives: Drug: Placebo Cream
Panel E and Extension - MK-0873 200 mg	Experimental	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. Receives: Drug: MK-0873 Cream
Panel E and Extension - Placebo	Placebo comparator	In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days. Receives: Drug: Placebo Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Day 22 in Part 1
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
Measured: Day 11
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.
Measured: 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
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.
Measured: Up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20101 Mar 2011

First posted9 Jun 2010 (estimated)
Study start1 May 2010
Primary completion1 Mar 2011
Study completion1 Mar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01140061
Sponsor's protocol ID: 0873-020
Status last verified: Jan 2019
First submitted: 7 Jun 2010
Last updated: 8 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
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Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01140061
Acronym / sponsor ID: 0873-020
Conditions: Plaque Psoriasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 May 2010 (actual)
Primary completion: 1 Mar 2011 (actual)
Study completion: 1 Mar 2011 (actual)
First posted: 9 Jun 2010 (estimated)
Results: Posted 12 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Panel A - MK-0873 5.1 mg	Experimental	Drug: MK-0873 Patch, Drug: Placebo Patch, Drug: Plain patchIn 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 comparator	Drug: Placebo Patch, Drug: Plain patchIn Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.
Panel B - MK-0873 25 mg	Experimental	Drug: MK-0873 CreamIn 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 comparator	Drug: Placebo CreamIn Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Panel C - MK-0873 100 mg	Experimental	Drug: MK-0873 CreamIn 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 C - Placebo	Placebo comparator	Drug: Placebo CreamIn Part II, healthy participants received skin application of placebo cream once daily for 10 days.
Panel D - MK-0873 200 mg	Experimental	Drug: MK-0873 CreamIn 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 D - Placebo	Placebo comparator	Drug: Placebo CreamIn Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
Panel E and Extension - MK-0873 200 mg	Experimental	Drug: MK-0873 CreamIn 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 E and Extension - Placebo	Placebo comparator	Drug: Placebo CreamIn Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;
Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;

Key exclusion criteria (9 listed)

Has a history of stroke, chronic seizures or major neurological disease;
Has a history of cancer;
Is a nursing mother;
Has nonplaque forms of psoriasis;
Has current drug-induced psoriasis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-0873 PatchMK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873	Drug	Panel A - MK-0873 5.1 mg
MK-0873 CreamMK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873	Drug	Panel B - MK-0873 25 mg, Panel C - MK-0873 100 mg, Panel D - MK-0873 200 mg, Panel E and Extension - MK-0873 200 mg
Placebo PatchPlacebo patches matching MK-0873 0.05%, 0.5%, or 2% patches	Drug	Panel A - MK-0873 5.1 mg, Panel A - Placebo
Placebo CreamPlacebo cream matching MK-0873 0.05%, 0.5%, or 2%	Drug	Panel B - Placebo, Panel C - Placebo, Panel D - Placebo, Panel E and Extension - Placebo
Plain patchPlain patch containing no MK-0873 or placebo	Drug	Panel A - MK-0873 5.1 mg, Panel A - Placebo

Primary outcome

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.
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
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.
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.

Results and safety

Results posted to the registry on 12 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panel A - MK-0873 5.1 mg	7	6
Panel A - Placebo	2	2
Panel B - MK-0873 25 mg	0	0
Panel B - Placebo	0	0
Panel C - MK-0873 100 mg	0	0
Panel C - Placebo	0	0
Panel D - MK-0873 200 mg	0	0
Panel D - Placebo	0	0
Panel E and Extension - MK-0873 200 mg	0	0
Panel E and Extension - Placebo	0	0

Primary outcome: Number of Participants With an Adverse Event of Erythema in Part I of the Study

Time frame: Up to Day 22 in Part 1. Number. Unit: Participants

Measure	Panel A - MK-0873 5.1 mg n = 7	Panel A - Placebo n = 2
Value	0	0

Population analysed: The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study.

Primary outcome: Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days

Time frame: Day 11. Mean (Standard Deviation). Unit: nM

Measure	Panel A - MK-0873 5.1 mg n = 6	Panel B - MK-0873 25 mg n = 6	Panel C - MK-0873 100 mg n = 6	Panel D - MK-0873 200 mg n = 6	Panel E and Extension - MK-0873 200 mg n = 6
Value	NA (NA)	9.10 (1.52)	5.22 (2.97)	12.0 (3.41)	9.76 (6.42)

Population analysed: The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax.

Primary outcome: Number of Participants With an Adverse Event

Time frame: Up to 14 days after last dose of study drug (up to Day 42). Number. Unit: Participants

Measure	Panel A - MK-0873 5.1 mg n = 7	Panel B - MK-0873 25 mg n = 6	Panel C - MK-0873 100 mg n = 6	Panel D - MK-0873 200 mg n = 6	Panel E and Extension - MK-0873 200 mg n = 7	Placebo - Pooled n = 10
Value	3	3	4	6	6	4

Population analysed: The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available.

Primary outcome: Number of Participants Who Discontinued Study Medication Due to an Adverse Event

Time frame: Up to Day 28. Number. Unit: Participants

Measure	Panel A - MK-0873 5.1 mg n = 7	Panel B - MK-0873 25 mg n = 6	Panel C - MK-0873 100 mg n = 6	Panel D - MK-0873 200 mg n = 6	Panel E and Extension - MK-0873 200 mg n = 7	Placebo - Pooled n = 10
Value	1	0	0	0	0	0

Population analysed: The population consisted of all enrolled participants who received at least one dose of study medication.

Adverse events

Time frame: Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panel A - MK-0873 5.1 mg	0 of 7 (0%)	3 of 7 (42.9%)	Not reported
Panel B - MK-0873 25 mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
Panel C - MK-0873 100 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Panel D - MK-0873 200 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported
Panel E and Extension - MK-0873 200 mg	0 of 7 (0%)	6 of 7 (85.7%)	Not reported
Placebo - Pooled	0 of 10 (0%)	4 of 10 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Plaque Psoriasis

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
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Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
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RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-0873 Patch, MK-0873 Cream and Plain patch in people with Plaque Psoriasis, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With an Adverse Event of Erythema in Part I of the Study (time frame: Up to Day 22 in Part 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01140061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.