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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


Phase 1
18 Years
75 Years
Not Enrolling
Both
Psoriasis

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment

Outcome Measure:

change in Maximum dermal interstitial concentration of BCT194

Outcome Description:

Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints

Outcome Time Frame:

Day 1 and day 8

Safety Issue:

No

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

CBCT194A2102

NCT ID:

NCT01539915

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Psoriasis
  • Psoriasis
  • Stable plaque psoriasis
  • lesions
  • TNF-alpha
  • BCT194
  • Psoriasis

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