Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients
A Single Center, Open Label Exploratory Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Topically Administered BCT194 in Dermal Interstitial Fluid in Psoriatic Patients Using Open Flow Microperfusion
2 other identifiers
interventional
12
1 country
1
Brief Summary
This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
February 28, 2012
CompletedFebruary 28, 2012
February 1, 2012
7 months
February 22, 2012
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change in Maximum dermal interstitial concentration of BCT194
Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints
Day 1 and day 8
Area under the curve interstitial concentrations of BCT194
Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints
day 1 and day 8
Secondary Outcomes (4)
Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)
day 1 and day 8
Change in plaque PASI scores of psoriasis lesions
day 1 and day 8
BCT194 concentrations in skin biopsies
day 1 and day 8
Change in Local tolerability score
Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13
Study Arms (1)
BCT194
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male patients and post menopausal or surgically sterile female patients aged 18 - 75 years.
- Diagnosis of stable plaque psoriasis (with or without arthritis); diagnosed or history of psoriasis for at least 6 months prior to screening
- Psoriatic plaques accessible for microperfusion at body sites (e.g. trunk) convenient for the patients.
You may not qualify if:
- Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
- Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus.
- Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or other disease which would make the patient unsuitable for the trial.
- Presence of major chronic inflammatory autoimmune diseases like rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematosus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Graz, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2012
First Posted
February 28, 2012
Study Start
April 1, 2007
Primary Completion
November 1, 2007
Last Updated
February 28, 2012
Record last verified: 2012-02