Phase 1
Completed N=9
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
Source: ClinicalTrials.gov NCT01140061 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Number of Participants With an Adverse Event of Erythema in Part I of the Study — 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event of Erythema in Part I of the Study |
0; 0 | — |
| PRIMARY Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days |
NA; 9.10; 5.22; 12.0; 9.76 | — |
| PRIMARY Number of Participants With an Adverse Event |
3; 3; 4; 6; 6; 4 | — |
| PRIMARY Number of Participants Who Discontinued Study Medication Due to an Adverse Event |
1; 0; 0; 0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01140061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.