Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: 122-0551

• Registration Number: NCT01698333
• Lead Sponsor: Therapeutics, Inc.

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 available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-03
• Primary Completion: 2013-03
• Study Completion: 2013-07
• Disposition First Submitted: 2013-11-25
• Disposition First Submitted QC: 2013-11-25
• Disposition First Posted: 2013-12-19
• Results First Submitted: 2018-08-30
• Results First Submitted QC: 2018-08-30
• Status Verified: 2018-09
• Results First Posted: 2018-09-26
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
122-0551	122-0551	-

Primary Outcome Measures

Name	Time	Method
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response	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.

Trial Locations

Locations (3)

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States