Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01698333
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):
Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: 122-0551 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 122-0551 Drug: 122-0551
Applied twice daily for 2 weeks

Primary Outcome Measures :
  1. Hypothalamic-Pituitary-Adrenal (HPA) axis response [ Time Frame: Day 15 ]
    HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". An 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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., propanolol) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01698333

United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Therapeutics, Inc.
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.

Responsible Party: Therapeutics, Inc. Identifier: NCT01698333     History of Changes
Other Study ID Numbers: 122-0551-202
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: November 2013

Keywords provided by Therapeutics, Inc.:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases