Clinical Trial: Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Therapeutics, Inc.

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Therapeutics, Inc.

Dates:
Date Received: September 27, 2012
Date Started: March 2012
Date Completion:
Last Updated: November 25, 2013
Last Verified: November 2013