Clinical trial NCT01698333: Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: 122-0551
steroid
HPA
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
affiliation: Therapeutics, Inc.
name: Syd Dromgoole, PhD
role: STUDY_DIRECTOR
References: