A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin

Exclusion Criteria

• •Poor metabolizer of warfarin as determined by CYP2C9 genotype testing.
• •Clinically significant PT, aPTT, INR, protein C, protein S, or platelet count results or hematuria.
• •Abnormal prolongation of skin bleeding time or a personal or family history of coagulation or bleeding disorders, vascular malformations including aneurysms, or venous thromboembolism.
• •Active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease.
• •Active malignancy of any type other than nonmelanomatous skin malignancies.
• •Use of any prescribed or over-the-counter concomitant medications within 14 days before the first dose of investigational product without approval of the Investigator and Sponsor.
• •Positive test result for drugs of abuse, alcohol, or cotinine or history of alcohol abuse or drug addiction.
• •Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV.