Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Therapeutics, Inc.

Status and phase

Completed

Phase 2

Conditions

Plaque Psoriasis

Treatments

Drug: 122-0551

Study type

Interventional

Funder types

Industry

Identifiers

NCT01698333

122-0551-202

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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