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Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients

NCT ID: NCT01539915

Last Updated: 2012-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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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

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Conditions

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Psoriasis

Keywords

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Psoriasis Stable plaque psoriasis lesions TNF-alpha BCT194

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Study Groups

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BCT194

Group Type EXPERIMENTAL

BCT194

Intervention Type DRUG

Topically applied BCT194 cream (0.5%)

Interventions

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BCT194

Topically applied BCT194 cream (0.5%)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2006-004690-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBCT194A2102

Identifier Type: -

Identifier Source: org_study_id