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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
  Purpose

This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.


Condition Intervention Phase
Psoriasis
 Drug: BCT194
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Novartis:

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.



Enrollment: 12
Study Start Date: April 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BCT194 Drug: BCT194
Topically applied BCT194 cream (0.5%)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539915

Locations
Austria
Novartis Investigative Site
Graz, Austria
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01539915     History of Changes
Other Study ID Numbers: CBCT194A2102, 2006-004690-10
Study First Received: February 22, 2012
Last Updated: February 27, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Novartis:
Psoriasis
Stable plaque psoriasis
lesions
TNF-alpha
BCT194

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013