Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels
Phase 2
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Drug: ISIS 301012 or Placebo
- Registration Number
- NCT00216463
- Lead Sponsor
- Kastle Therapeutics, LLC
- Brief Summary
The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- BMI >/= 25 to </= 32 kg/m^2
- fasting stable LDL-cholesterol >/= 130 mg/dL (3.36 mmol/L) and triglycerides < 400 mg/dL (4.55 mmol/L)
- Females not of childbearing potential
Exclusion Criteria
- No endocrine, hematologic, renal, hepatic, metabolic, psychiatric, neurology, pulmonary or cardiovascular disease
- Subjects who test positive for hepatitis B, C or HIV
- Current diagnosis or known history of liver disease, such as acute or chronic hepatitis, liver cirrhosis, liver steatosis, or liver function abnormalities such as AST, ALT, GGT, or total bilirubin >/= 1.5 x ULN at Screening
- A systolic blood pressure >/= 160 mmHg or a diastolic blood pressure >/= 95 mmHg on 2 occasions during Screening
- Concomitant medications within 14 days of dosing, except hormone replacement therapy for post-menopausal women and acetylsalicylic acid or paracetamol dosed for fewer than five consecutive days
- Subject has taken any lipid-lowering drug within 30 days or five half-lives (of the lipid-lowering drug) whichever is longer, prior to Screening
- Alcohol or drug abuse within 2 years of Screening
- Donated blood (450 mL) within the 3 months prior to Screening or suffered significant blood loss equal to a blood donor portion
- Subject smokes > 10 cigarettes, or more than one pipe or one cigar per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A ISIS 301012 or Placebo Slow load with every other week maintenance B ISIS 301012 or Placebo Slow load with every other week maintenance C ISIS 301012 or Placebo No load; once weekly maintenance D ISIS 301012 or Placebo No load; once weekly maintenance E ISIS 301012 or Placebo No load; once weekly maintenance
- Primary Outcome Measures
Name Time Method Percent reduction in LDL-cholesterol from baseline 14 days post dosing
- Secondary Outcome Measures
Name Time Method Percent reduction in apoB-100 from baseline 14 days post dosing Percent change from baseline in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL and LP(a) 14 days post dosing Percent change from baseline in LDL/HDL and apoB-100/apo-A1 ratios 14 days post dosing