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

September 27, 2012
November 25, 2013
March 2012
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01698333 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Plaque Psoriasis
Drug: 122-0551
Applied twice daily for 2 weeks
Experimental: 122-0551
Intervention: Drug: 122-0551
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01698333
122-0551-202
No
Therapeutics, Inc.
Therapeutics, Inc.
Not Provided
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.
Therapeutics, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP