Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01698333
First received: September 27, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Plaque Psoriasis
Drug: 122-0551
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Therapeutics, Inc.:

Primary Outcome Measures:
  • Hypothalamic-Pituitary-Adrenal (HPA) axis response [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 122-0551 Drug: 122-0551
Applied twice daily for 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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., 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698333

Locations
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.
Investigators
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01698333     History of Changes
Other Study ID Numbers: 122-0551-202
Study First Received: September 27, 2012
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Therapeutics, Inc.:
122-0551
steroid
HPA

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014