IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Trial record 1 of 5 for:
ALN-PCSsc
A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
This study has been completed.
Sponsor:
Alnylam Pharmaceuticals
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02314442
First received: December 5, 2014
Last updated: December 16, 2015
Last verified: December 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.
| Condition | Intervention | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: ALN-PCSSC Drug: Sterile Normal Saline (0.9% NaCl) | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment |
| Official Title: | A Phase 1, Randomized, Single Blind, Placebo Controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN PCSSC in Subjects With Elevated Low Density Lipoprotein Cholesterol |
Resource links provided by NLM:
Further study details as provided by Alnylam Pharmaceuticals:
Primary Outcome Measures:
- The safety of ALN-PCSSC evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation [ Time Frame: Part 1 (SAD phase): up to 180 days post dose; Part 2 (MD) phase: up to 180 days post final dose ]
Secondary Outcome Measures:
- The pharmacokinetics (PK) of ALN-PCSSC (Cmax, tmax, AUC, t1/2) [ Time Frame: Part 1 (SAD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 42, 56 days post-dose; Part 2 (MD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 29, 35, 42, 56, 84 days post-dose ]
- The effect of ALN-PCSSC on serum levels of LDL-C [ Time Frame: Through the sooner of final follow up visit or 180 days post final dose ]
- The effect of ALN-PCSSC on plasma levels of PCSK9 [ Time Frame: Through the sooner of final follow up visit or 180 days post final dose ]
| Enrollment: | 70 |
| Study Start Date: | December 2014 |
| Study Completion Date: | November 2015 |
| Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: ALN-PCSSC |
Drug: ALN-PCSSC
Single or multiple doses of ALN-PCSSC by subcutaneous (sc) injection
|
| 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 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Adequate complete blood counts, liver and renal function
- Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization
- Male subjects agree to use appropriate contraception
- Willing to provide written informed consent and willing to comply with study requirements.
- Non-smokers and non-nicotine users for at least 90 days before screening
- On stable statin co-medication [for designated multiple dose cohorts only]
Exclusion Criteria:
- Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk
- Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
- History of multiple drug allergies or intolerance to subcutaneous injection
- Received any medication or nutraceutical to alter serum lipids within 30 days before screening (non-statin cohorts only)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02314442
Please refer to this study by its ClinicalTrials.gov identifier: NCT02314442
Locations
| United Kingdom | |
| Covance Clinical Research Unit | |
| Leeds, United Kingdom | |
| Richmond Pharmacology | |
| London, United Kingdom | |
Sponsors and Collaborators
Alnylam Pharmaceuticals
The Medicines Company
Investigators
| Study Director: | Robert Kauffman, MD | Alnylam Pharmaceuticals |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alnylam Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02314442 History of Changes |
| Other Study ID Numbers: |
ALN-PCSSC-001 |
| Study First Received: | December 5, 2014 |
| Last Updated: | December 16, 2015 |
Keywords provided by Alnylam Pharmaceuticals:
|
LDL-C RNAi therapeutic |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on July 27, 2017