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Trial record 1 of 1 for:    pop12671
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Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

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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

Tracking Information
First Submitted Date  ICMJE August 16, 2012
First Posted Date  ICMJE August 22, 2012
Last Update Posted Date June 28, 2013
Study Start Date  ICMJE September 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727) [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
Pharmacokinetics: Assessment of serum concentrations of SAR236553 (REGN727) [ Time Frame: Up to 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
  • Assessment of PK parameter - terminal elimination half-life (t1/2z) [ [ Time Frame: Up to 12 weeks ]
  • Assessment of PK parameter - apparent total body clearance (CL/F) [ Time Frame: Up to 12 weeks ]
  • Assessment of PK parameter - Distribution volume at the steady-state (Vss/F) [ Time Frame: Up to 12 weeks ]
  • Assessment of PK parameter - time to maximum concentration (tmax) [ Time Frame: Up to 12 weeks ]
  • Assessment of PK parameter - Mean Residence Time (MRT [area]) [ Time Frame: Up to 12 weeks ]
  • Pharmacodynamics: Change in LDL-C from baseline [ Time Frame: Up to 12 weeks ]
  • Number of participants with Adverse Events [ Time Frame: Up to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Total duration of the study per subject (excluding screening) is about 12 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE 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

Study Arms  ICMJE
  • Experimental: alirocumab SAR236553 (REGN727) - mild hepatic function
    Injection through subcutaneous (SC) administration in patients with mild hepatic function
    Intervention: Drug: alirocumab SAR236553 (REGN727)
  • Experimental: alirocumab SAR236553 (REGN727) - moderate hepatic function
    Injection through subcutaneous (SC) administration in patients with moderate hepatic function
    Intervention: Drug: alirocumab SAR236553 (REGN727)
  • Experimental: alirocumab SAR236553 (REGN727) - normal hepatic function
    Injection through subcutaneous (SC) administration in patients with normal hepatic function
    Intervention: Drug: alirocumab SAR236553 (REGN727)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2013)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2012)
24
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Moldova, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01670734
Other Study ID Numbers  ICMJE POP12671
2012-002292-33
U1111-1129-0248 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sanofi
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sanofi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP