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

NCT ID: NCT00417820

Last Updated: 2007-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

BCT194

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

All participants:

• Healthy male and female (of non-childbearing potential) subjects age 18 to 45 years of age included, and in good health as determined by past medical history Postmenopausal women must have had no regular menstrual bleeding for at least 1 year prior to inclusion or female subjects must have been surgically sterilized at least 6 months prior to screening supported by clinical documentation.

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.

Exclusion Criteria

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.

Psoriasis patients:

• 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).
• Used any investigational drug within the previous 4 weeks.
• Recent previous treatment with anti-TNF-α therapy (or other biological therapy),immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative Site

Vienna, , Austria

Countries

Austria

Other Identifiers

CBCT194A2101

Identifier Type: -

Identifier Source: org_study_id