 - Presence of any of the following clinical conditions: Substance abuse within the past year; Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease; autoimmune deficiency syndrome AIDS or AIDS-related complex; Clinically active psoriasis within 30 days of the Screening Visit; Unstable psychiatric illness defined as psychosis hallucinations or delusions or untreated major depression within 90 days of the Screening Visit; Screening serum creatinine greater than or equal to 1.5 mgdL 133 umolL, thyroid stimulating hormone TSH 20 above the upper limit; Presence of any clinically significant conduction abnormalities on electrocardiogram ECG; or Lactating or have a positive serum pregnancy test at the Screening Visit. 