Dose-escalating Safety Study in Subjects on Stable Statin Therapy

K

Kastle Therapeutics

Status and phase

Completed

Phase 2

Conditions

Hypercholesterolemia

Treatments

Drug: ISIS 301012 or Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00231569

301012CS4

EudraCT No.: 2005-002119-26

Details and patient eligibility

About

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

Enrollment

74 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

74 participants in 7 patient groups

Cohort A

Experimental group

Description: