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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Panel A - Placebo | Placebo Comparator | In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days. |
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| 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. |
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| Panel B - Placebo | Placebo Comparator | In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0873 Patch | Drug | MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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. |
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Inclusion Criteria:
Part I, II and III:
Part III only:
Exclusion Criteria:
Part I, II and III:
Part III only:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A - MK-0873 5.1 mg | In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days. |
| FG001 | Panel A - Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part I |
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| Panel C - Placebo | Placebo Comparator | In Part II, healthy participants received skin application of placebo cream once daily for 10 days. |
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| 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. |
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| Panel D - Placebo | Placebo Comparator | In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. |
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| 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. |
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| 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. |
|
| MK-0873 Cream |
| Drug |
MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873 |
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| Placebo Patch | Drug | Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches |
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| Placebo Cream | Drug | Placebo cream matching MK-0873 0.05%, 0.5%, or 2% |
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| Plain patch | Drug | Plain patch containing no MK-0873 or placebo |
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| Up to Day 28 |
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days. |
| FG002 | 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. |
| FG003 | Panel B - Placebo | In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. |
| FG004 | 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. |
| FG005 | Panel C - Placebo | In Part II, healthy participants received skin application of placebo cream once daily for 10 days. |
| FG006 | 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. |
| FG007 | Panel D - Placebo | In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. |
| FG008 | 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. |
| FG009 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Part II |
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| Part III |
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| Extension |
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A - MK-0873 5.1 mg | In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days. |
| BG001 | Panel A - Placebo | In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days |
| BG002 | 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. |
| BG003 | Panel B - Placebo | In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. |
| BG004 | 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. |
| BG005 | Panel C - Placebo | In Part II, healthy participants received skin application of placebo cream once daily for 10 days. |
| BG006 | 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 |
| BG007 | Panel D - Placebo | In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. |
| BG008 | 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. |
| BG009 | 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. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study. | Posted | Number | Participants | Up to Day 22 in Part 1 |
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| 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 | The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax. | Posted | Mean | Standard Deviation | nM | 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. | The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available. | Posted | Number | Participants | 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. | The population consisted of all enrolled participants who received at least one dose of study medication. | Posted | Number | Participants | Up to Day 28 |
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Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panel A - MK-0873 5.1 mg | In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days. | 0 | 7 | 3 | 7 | ||
| EG001 | 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. | 0 | 6 | 3 | 6 | ||
| EG002 | 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. | 0 | 6 | 4 | 6 | ||
| EG003 | 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. | 0 | 6 | 6 | 6 | ||
| EG004 | 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. | 0 | 7 | 6 | 7 | ||
| EG005 | Placebo - Pooled | In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis. | 0 | 10 | 4 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Burning Sensation | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection-site reaction | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Hyperaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Male |
|
| 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. |
| OG004 | 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. |
|
|
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.
| OG003 | 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. |
| OG004 | 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. |
| OG005 | Placebo - Pooled | In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis. |
|
|
| OG003 | 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. |
| OG004 | 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. |
| OG005 | Placebo - Pooled | In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis. |
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