- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01698333
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
September 28, 2018 updated by: Therapeutics, Inc.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Anaheim, California, United States, 92801
- Anaheim Clinical Trials
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San Diego, California, United States, 92123
- Therapeutics Clinical Research
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Texas
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Austin, Texas, United States, 78759
- Dermresearch, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 122-0551
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Applied twice daily for 2 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
Time Frame: 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.
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Day 15
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
September 27, 2012
First Submitted That Met QC Criteria
September 28, 2012
First Posted (Estimate)
October 3, 2012
Study Record Updates
Last Update Posted (Actual)
October 24, 2018
Last Update Submitted That Met QC Criteria
September 28, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 122-0551-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on 122-0551
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Mitsubishi Tanabe Pharma CorporationRecruiting
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Therapeutics, Inc.CompletedPlaque PsoriasisUnited States
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Therapeutics, Inc.CompletedA Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)Plaque PsoriasisUnited States
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Therapeutics, Inc.CompletedPlaque PsoriasisUnited States
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Santen Inc.CompletedAge-Related Macular DegenerationUnited States