Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01539915

First received: February 22, 2012

Last updated: February 27, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 22, 2012
Last Updated Date	February 27, 2012
Start Date ^ICMJE	April 2007
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 27, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01539915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 27, 2012)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment
Condition ^ICMJE	Psoriasis
Intervention ^ICMJE	Drug: BCT194 Topically applied BCT194 cream (0.5%)
Study Arm (s)	Experimental: BCT194 Intervention: Drug: BCT194
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	Not Provided
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria: 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. Exclusion criteria: 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.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria

Administrative Information
NCT Number ^ICMJE	NCT01539915
Other Study ID Numbers ^ICMJE	CBCT194A2102, 2006-004690-10
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis ( Novartis Pharmaceuticals )
Study Sponsor ^ICMJE	Novartis Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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