Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698333
• Other study ID #: 122-0551-202
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2018
• Source: Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• 122-0551
Applied twice daily for 2 weeks

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	DermResearch, Inc.	Austin	Texas
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothalamic-Pituitary-Adrenal (HPA) Axis Response	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.	Day 15