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Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01670734
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).

Secondary Objectives:

  • Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.
  • Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with hepatic impairment and in matched subjects with normal hepatic function.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: alirocumab SAR236553 (REGN727) Phase 1

Detailed Description:
Total duration of the study per subject (excluding screening) is about 12 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Pharmacokinetic and Tolerability Study of SAR236553/REGN727 Given as a Single SC Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function
Study Start Date : September 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: alirocumab SAR236553 (REGN727) - mild hepatic function
Injection through subcutaneous (SC) administration in patients with mild hepatic function
Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Experimental: alirocumab SAR236553 (REGN727) - moderate hepatic function
Injection through subcutaneous (SC) administration in patients with moderate hepatic function
Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Experimental: alirocumab SAR236553 (REGN727) - normal hepatic function
Injection through subcutaneous (SC) administration in patients with normal hepatic function
Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Pharmaceutical form:Solution for injection Route of administration: subcutaneous




Primary Outcome Measures :
  1. Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727) [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Assessment of PK parameter - terminal elimination half-life (t1/2z) [ [ Time Frame: Up to 12 weeks ]
  2. Assessment of PK parameter - apparent total body clearance (CL/F) [ Time Frame: Up to 12 weeks ]
  3. Assessment of PK parameter - Distribution volume at the steady-state (Vss/F) [ Time Frame: Up to 12 weeks ]
  4. Assessment of PK parameter - time to maximum concentration (tmax) [ Time Frame: Up to 12 weeks ]
  5. Assessment of PK parameter - Mean Residence Time (MRT [area]) [ Time Frame: Up to 12 weeks ]
  6. Pharmacodynamics: Change in LDL-C from baseline [ Time Frame: Up to 12 weeks ]
  7. Number of participants with Adverse Events [ Time Frame: Up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Male or female, between 18 to 75 years of age, inclusive.
  • Patients with mild and moderate hepatic impairment based on Child-Pugh score and stable chronic liver disease.
  • Healthy subjects with normal hepatic function.

Exclusion criteria:

  • Patients with acute hepatitis, hepatic encephalopathy grade 2, 3, and 4.
  • Patients with history or presence of uncontrolled clinically relevant illness.
  • Healthy subjects with history or presence of clinically relevant illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT01670734


Locations
France
Investigational Site Number 250001
Rennes, France, 35000
Moldova, Republic of
Investigational Site Number 498001
Chisinau, Moldova, Republic of, 2025
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01670734     History of Changes
Other Study ID Numbers: POP12671
2012-002292-33
U1111-1129-0248 ( Other Identifier: UTN )
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs