Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-07-31

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.

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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122-0551

Group Type EXPERIMENTAL

122-0551

Intervention Type DRUG

Applied twice daily for 2 weeks

Interventions

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122-0551

Applied twice daily for 2 weeks

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No