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Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

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ClinicalTrials.gov Identifier: NCT01698333
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : September 26, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 27, 2012
First Posted Date  ICMJE October 3, 2012
Results First Submitted Date  ICMJE August 30, 2018
Results First Posted Date  ICMJE September 26, 2018
Last Update Posted Date October 24, 2018
Study Start Date  ICMJE April 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response [ Time Frame: Day 15 ]
HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". Laboratory evidence of 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
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.
Change History Complete list of historical versions of study NCT01698333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE Drug: 122-0551
Applied twice daily for 2 weeks
Study Arms  ICMJE Experimental: 122-0551
Intervention: Drug: 122-0551
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2013)
25
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2012)
20
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01698333
Other Study ID Numbers  ICMJE 122-0551-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutics, Inc.
Study Sponsor  ICMJE Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.
PRS Account Therapeutics, Inc.
Verification Date September 2018

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