Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
This study is currently recruiting participants.
Verified September 2012 by Therapeutics, Inc.
Sponsor:
Therapeutics, Inc.
Information provided by (Responsible Party):
Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01698333
First received: September 27, 2012
Last updated: September 28, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Plaque Psoriasis |
Drug: 122-0551 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Therapeutics, Inc.:
Primary Outcome Measures:
- Hypothalamic-Pituitary-Adrenal (HPA) axis response [ Time Frame: Day 15 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 122-0551 |
Drug: 122-0551
Applied twice daily for 2 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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., propanolol) 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698333
Locations
| United States, California | |
| Anaheim Clinical Trials | Recruiting |
| Anaheim, California, United States, 92801 | |
| Contact: Christine Rivera 714-774-7777 crivera@act-trials.com | |
| Principal Investigator: Peter Winkle, MD | |
| Therapeutics Clinical Research | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Lisa Duarte 858-571-6800 lduarte@therapeuticsresearch.com | |
| Principal Investigator: Eugene Huang, MD, PhD | |
| United States, Texas | |
| DermResearch, Inc. | Recruiting |
| Austin, Texas, United States, 78759 | |
| Contact: Michelle Haile 512-349-9889 mhaile@dermresearch.net | |
| Principal Investigator: Michael Jarratt, MD | |
Sponsors and Collaborators
Therapeutics, Inc.
Investigators
| Study Director: | Syd Dromgoole, PhD | Therapeutics, Inc. |
More Information
No publications provided
| Responsible Party: | Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01698333 History of Changes |
| Other Study ID Numbers: | 122-0551-202 |
| Study First Received: | September 27, 2012 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Therapeutics, Inc.:
|
122-0551 steroid HPA |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013