Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

NCT01698333 | Completed Phase 2 Results

• 1 other identifier: 122-0551-202
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Plaque Psoriasis

Keywords

122-0551; steroid; HPA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

122-0551

EXPERIMENTAL

Drug: 122-0551

Interventions

122-0551 DRUG

Applied twice daily for 2 weeks

122-0551

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a clinical diagnosis of stable plaque psoriasis

You may not qualify if:

• 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

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (3)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Results Point of Contact

• Title: Clinical Research
• Organization: Therapeutics Inc.

clinicalresearch@therapeuticsinc.com

858-571-1800

Study Officials

• Syd Dromgoole, PhD

  Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 3, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 24, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-09

Locations

US (3)