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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess how blood clotting and thinning time is effected when a single dose of warfarin is given alone and when a single dose of warfarin is given with mipomersen; to assess the blood levels of a single dose of warfarin, a single dose of mipomersen, and a single dose of warfarin when given with mipomersen; and to assess the safety of mipomersen when given with or without warfarin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kastle Therapeutics, LLC
• Collaborator: Ionis Pharmaceuticals, Inc.
• Treatments: Mipomersen; Warfarin

Criteria

Inclusion Criteria:

• Written informed consent before any study-related procedure is performed.

• Body mass index (BMI) between 18 and 32 kg/m2, inclusive.

• No clinically significant abnormalities based on medical history, laboratory assessments, vital sign, 12-lead electrocardiogram (ECG) results, and physical examination.

• Subjects willing and able to follow a prescribed diet.

• Subjects have not consumed nicotine or nicotine-containing products for at least 6 months before Screening.

• Subjects are nonpregnant and nonlactating, surgically sterile, postmenopausal, abstinent, or the subject or partner is willing to use a reliable method of contraception during the study and for 5 months after mipomersen dosing.

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.