Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Study Overview
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Brief Summary
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Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.

Official Title
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An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: 122-0551


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a clinical diagnosis of stable plaque psoriasis Exclusion Criteria: Subject has spontaneously improving or rapidly deteriorating plaque psoriasis Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis Subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy within 30 days prior to initiation of treatment Subject has used systemic corticosteroids or topical, inhaled, intranasal corticosteroids within 30 days and 14 days, respectively, prior to study screening Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to initiation of treatment Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to initiation of treatment Subject has used emollients/moisturizers on areas to be treated within one day prior to initiation of treatment Subject is currently using lithium or Plaquenil (hydroxychloroquine) Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized Subject is pregnant, nursing or planning a pregnancy during the study period Subject is currently enrolled in an investigational drug, biologic or device study Subject has received an investigational drug, biologic or an investigational device within 30 days prior to study start Subject has been previously enrolled in this study and treated with the test article Subject has an irregular sleep schedule or works night shifts

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 122-0551<br> | Drug: 122-0551<br>* Applied twice daily for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothalamic-Pituitary-Adrenal (HPA) Axis Response | HPA axis response to stimulation by cosyntropin, dichotomized to normal and abnormal. Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study. | Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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122-0551, steroid, HPA