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Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
122-0551
Sponsored by
Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring 122-0551, steroid, HPA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anaheim Clinical Trials
  • Therapeutics Clinical Research
  • DermResearch, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

122-0551

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2012
Last Updated
September 28, 2018
Sponsor
Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01698333
Brief Title
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
122-0551, steroid, HPA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
122-0551
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
122-0551
Intervention Description
Applied twice daily for 2 weeks
Primary Outcome Measure Information:
Title
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
Description
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.
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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., 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syd Dromgoole, PhD
Organizational Affiliation
Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

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