Trial record 1 of 9 for:
ALN-PCSsc
A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
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| ClinicalTrials.gov Identifier: NCT02314442 |
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Recruitment Status :
Completed
First Posted : December 11, 2014
Last Update Posted : December 17, 2015
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Sponsor:
Alnylam Pharmaceuticals
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: ALN-PCSSC Drug: Sterile Normal Saline (0.9% NaCl) | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 70 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (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 |
| Study Start Date : | December 2014 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | November 2015 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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 |
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 ]
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| 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 |
| First Posted: | December 11, 2014 Key Record Dates |
| Last Update Posted: | December 17, 2015 |
| Last Verified: | December 2015 |
Keywords provided by Alnylam Pharmaceuticals:
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LDL-C RNAi therapeutic |
Additional relevant MeSH terms:
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Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |