Study of the Safety, Tolerability and Efficacy of BCT194 in Healthy Volunteers and Patients With Psoriasis.

NCT00417820 | Completed Phase 1

• 1 other identifier: CBCT194A2101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the local tolerability of a single topical administration of BCT194 in healthy volunteers and, potentially, to evaluate the safety, tolerability, and efficacy of a multiple topical administrations in patients with psoriasis.

Conditions

Psoriasis

Keywords

Safety, tolerability, pharmacodynamics, single administration, BCT194, healthy volunteers, psoriasis

Outcome Measures

Primary Outcomes (2)

• Safety & tolerability

• Efficacy as assessed by plaque Psoriasis Area and Severity Index (PASI) scoring at 4 weeks

Secondary Outcomes (3)

• Potential of absorption of topical BCT194 into the systemic circulation and to determine skin exposure

• Cellular changes in psoriasis skin by immunohistology at day 8

• Changes in HSP-27 and phospho (p) HSP-27 in protein lysates of skin biopsies at Day 8

Interventions

BCT194 DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants:
• Male subjects must be using a double-barrier local contraception.
• Body weight must be between 50 and 100kg (inclusive) to participate in this study
• Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
• Psoriasis patients:
• Diagnosis of stable plaque psoriasis with or without arthritis for at least 6 months prior to screening.
• Absence of clinically relevant abnormalities for screening laboratory test results of hematological (hemoglobin, white blood cells, neutrophils, platelets), renal (serum creatinine) and hepatic (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gammaglutamyltransferase,bilirubin) parameters.
• Willingness to avoid sunbeds or unusual sun exposure during the study period.

You may not qualify if:

• All participants:
• Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable,
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
• Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
• Significant illness within two weeks prior to dosing.
• A past personal or close family medical history of clinically significant cardiac abnormalities
• History of:
• Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
• Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
• Known hypersensitivity or severe adverse event to darifenacin or similar drugs
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study
• Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result
• Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
• Drug or alcohol abuse within the 6 months prior to dosing.
• History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks prior to study start, including tanning, sunbeds etc.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

Vienna, Austria

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: November 1, 2006
• Study Completion: November 1, 2007
• Last Updated: November 29, 2007

Record last verified: 2007-11

Locations

AU (1)