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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01133366

Run by

Kastle Therapeutics, LLC

People needed

18

Starts

2010-05-01

Expected to finish

2010-07-01

Last updated by the study team

2016-08-03

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

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