Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)
This study has been completed.
Sponsor:
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01437059
First received: September 19, 2011
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Elevated LDL-Cholesterol (LDL-C) |
Drug: ALN-PCS02 Drug: Sterile Normal Saline (0.9% NaCl) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Phase 1, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C) |
Resource links provided by NLM:
Further study details as provided by Alnylam Pharmaceuticals:
Primary Outcome Measures:
- The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation. [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics (PK) of ALN-PCS02 (Cmax, tmax, t1/2, AUC0-last, CL). [ Time Frame: Up to 180 days ] [ Designated as safety issue: Yes ]
- Effect of ALN-PCS02 on Circulating PCSK9 Levels (Determination of % Lowering of PCSK9 to pretreatment/Baseline PCSK9 Level). [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
- Effect of ALN-PCS02 on Circulating LDL-c Levels (Determination of % Lowering of LDL-c to pretreatment/Baseline LDL-c Level). [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | September 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: ALN-PCS02 |
Drug: ALN-PCS02
Dose levels between 15 and 400 μg/kg by intravenous (IV) infusion
|
| Placebo Comparator: Sterile Normal Saline (0.9% NaCl) |
Drug: Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437059
Locations
| United Kingdom | |
| Clinical Site | |
| Leeds, United Kingdom, LS2 9LH | |
| Clinical Site | |
| London, United Kingdom, SE1 1YR | |
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
| Study Director: | Amy Simon, MD | Alnylam Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Alnylam Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01437059 History of Changes |
| Other Study ID Numbers: | ALN-PCS02-001 |
| Study First Received: | September 19, 2011 |
| Last Updated: | October 11, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
ClinicalTrials.gov processed this record on May 16, 2013