Status:
COMPLETED
Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Elevated LDL-Cholesterol (LDL-C)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol (LDL-C).
Eligibility Criteria
Inclusion
- Elevated LDL-C of \>3.0 mmol/L and \<5.7 mmol/L
- Fasting triglyceride concentration ≤2.8 mmol/L
- Body weight \>60.0 kg; body mass index (BMI) between 19.00 kg/m2 and \<35.00 kg/m2
- Adequate blood counts, liver and renal function
- May not received any lipid lowering drug/agent within the 30 days prior to the screening
- Non-smokers for at least 3 months
- Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control
- Males agree to use appropriate contraception
- Willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent
Exclusion
- Known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
- Multiple drug allergies or know sensitivity to oligonucleotide
- History of drug abuse and/or alcohol abuse
- Receiving an investigational agent within 3 months prior to study drug administration
- Subjects with safety laboratory test results deemed clinical significant by the Investigator;
- Received prescription drugs within 4 weeks of first dosing
- Subjects who have donated more than 500 mL of blood within the 3 months prior to ALN-PCS02 or placebo administration;
- Received megadose vitamin therapy or dietary supplements within 4 weeks prior to screening
- Subjects who have used prescription drugs within 4 weeks of first dosing
- Considered unfit for the study by the Principal Investigator
- Employee or family member of the sponsor or the clinical study site personnel
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01437059
Start Date
September 1 2011
End Date
September 1 2012
Last Update
October 12 2012
Active Locations (2)
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1
Clinical Site
Leeds, United Kingdom, LS2 9LH
2
Clinical Site
London, United Kingdom, SE1 1YR