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

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.