Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: February 22, 2012
Last updated: February 27, 2012
Last verified: February 2012
This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.
||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
||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
Primary Outcome Measures:
- change in Maximum dermal interstitial concentration of BCT194 [ Time Frame: Day 1 and day 8 ] [ Designated as safety issue: No ]
Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints
- Area under the curve interstitial concentrations of BCT194 [ Time Frame: day 1 and day 8 ] [ Designated as safety issue: No ]
Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints
Secondary Outcome Measures:
- Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha) [ Time Frame: day 1 and day 8 ] [ Designated as safety issue: No ]
Interstitial fluid will be collected and concentrations of Tumor Necrosis Factor alpha determined determined on Day 1 and Day 8 at several timepoints
- Change in plaque PASI scores of psoriasis lesions [ Time Frame: day 1 and day 8 ] [ Designated as safety issue: No ]
Treatment areas will be assessed clinically at baseline and Day 8
- BCT194 concentrations in skin biopsies [ Time Frame: day 1 and day 8 ] [ Designated as safety issue: No ]
Biopsies of lesional and nonlesional skin will be collected 4 hours post dose on Day 1 and Day 8 for measurement of BCT194 concentration.
- Change in Local tolerability score [ Time Frame: Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13 ] [ Designated as safety issue: Yes ]
Local tolerability assessed using a validated score (0-4) for each treatment area
Safety Issue: Treatment sites will be visually assessed for visible reaction to the treatment.
| Study Start Date:
| Primary Completion Date:
||November 2007 (Final data collection date for primary outcome measure)
Topically applied BCT194 cream (0.5%)
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539915
|Novartis Investigative Site
|Graz, Austria |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 22, 2012
||February 27, 2012
||Austria: Federal Office for Safety in Health Care
Keywords provided by Novartis:
Stable plaque psoriasis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Skin Diseases, Papulosquamous