Dose-escalating Safety Study in Subjects on Stable Statin Therapy

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on Stable statin therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• On a stable dose of >/= 40 mg Simvastatin or atorvastatin daily for >/= 3 months prior to baseline and expected to remain on this dose for the remainder of the study

• LDL-cholesterol between 2.60 and 5.70 mmol/L (100 and 220 mg/dL), inclusive at screening

• Females not of childbearing potential.

Exclusion Criteria:

• History of CHD or CHD-equivalent (such as diabetes mellitus, or another clinical form of atherosclerotic disease, e.g., peripheral arterial disease, abdominal aortic aneurysm, or symptomatic carotid artery disease)

• Fasting triglyceride >2.26 mmol/L (200 mg/dL) at screening

• Any uncontrolled medical/surgical/psychiatric condition, including conditions that may predispose to secondary hypercholesterolemia

• Current diagnosis or known history of complement deficiency or abnormality

• A positive hepatitis B surface antigen or hepatitis C antibody, or a known positive HIV status

• Current diagnosis or known history of liver disease, or has an ALT >ULN at screening

• Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or has a CPK >ULN at screening

• Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin that has been adequately treated

• The advisability of a subject taking any prescription medication (apart from simvastatin or atorvastatin) within 6 weeks prior to screening should be discussed with the Isis Medical Monitor

• Subject unwilling to discontinue taking alternative/herbal medication for the duration of the study

• History of drug abuse within 2 years of screening

• Subject unwilling to limit alcohol consumption for the duration of the study: male subjects to a maximum of 3 drinks (30 g) per day, and <12 drinks (120 g) per week; female subjects to a maximum of 2 drinks (20 g) per day, and <8 drinks (80 g) per week

• Known allergy or hypersensitivity to simvastatin

• Undergoing or has undergone treatment with another investigational drug, biologic agent, or device within 3 months, or 3 half lives, prior to screening, whichever is longer