Status:
TERMINATED
Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol
Lead Sponsor:
Arbutus Biopharma Corporation
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is pla...
Eligibility Criteria
Inclusion
- Fasting, stable LDL-C ≥ 160 mg/dL
- Fasting, stable triglyceride \< 400 mg/dL
- BMI between 22 and 35 kg/m2, inclusive
- Females must be of non-child bearing potential
- Males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion
Exclusion
- Clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease
- Cancer within 5 years prior to screening
- History of congestive heart failure or chronic heart failure
- Uncontrolled cardiac arrhythmias
- History of coronary heart disease
- Clinically significant abnormal baseline ECG
- History of additional risk factors for torsades de pointes
- Hepatitis B, C, or HIV positive
- Current diagnosis or known history of liver disease
- A marked baseline prolongation of QT/QTc interval
- Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (CPK) \>3 x upper limit of normal (ULN) at screening
- Alanine aminotransferase, AST, GGT, or total bilirubin \>2 x ULN at screening
- Serum creatinine \> 1.5 mg/dL
- Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 occasions during screening
- Concomitant use of medications that prolongs the QT/QTc interval
- Treatment with lipid lowering therapy within 30 days prior to screening
- Use of investigational drug within 3 months prior to screening
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00927459
Start Date
June 1 2009
End Date
January 1 2010
Last Update
January 22 2010
Active Locations (1)
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1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45212