Try our beta test site
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. Read more...
Trial record 1 of 5 for:    ALN-PCSsc
Previous Study | Return to List | Next Study

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:
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
  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

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 May 25, 2017