Status:
COMPLETED
Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00216463
Start Date
August 1 2005
End Date
August 1 2007
Last Update
August 3 2016
Active Locations (1)
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1
Berlin, Germany, D-14050