Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539915
• Other study ID #: CBCT194A2102
• Secondary ID: 2006-004690-10
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2012
• Last updated: February 27, 2012
• Start date: April 2007

Study information

• Verified date: February 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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-a 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.

Study Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BCT194
Topically applied BCT194 cream (0.5%)

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Maximum dermal interstitial concentration of BCT194	Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints	Day 1 and day 8	No
Primary	Area under the curve interstitial concentrations of BCT194	Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints	day 1 and day 8	No
Secondary	Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)	Interstitial fluid will be collected and concentrations of Tumor Necrosis Factor alpha determined determined on Day 1 and Day 8 at several timepoints	day 1 and day 8	No
Secondary	Change in plaque PASI scores of psoriasis lesions	Treatment areas will be assessed clinically at baseline and Day 8	day 1 and day 8	No
Secondary	BCT194 concentrations in skin biopsies	Biopsies of lesional and nonlesional skin will be collected 4 hours post dose on Day 1 and Day 8 for measurement of BCT194 concentration.	day 1 and day 8	No
Secondary	Change in Local tolerability score	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.	Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13	Yes