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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01670734
First received: August 16, 2012
Last updated: June 27, 2013
Last verified: June 2013

August 16, 2012
June 27, 2013
September 2012
May 2013   (final data collection date for primary outcome measure)
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics: Assessment of serum concentrations of SAR236553 (REGN727) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01670734 on ClinicalTrials.gov Archive Site
  • Assessment of PK parameter - terminal elimination half-life (t1/2z) [ [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - apparent total body clearance (CL/F) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - Distribution volume at the steady-state (Vss/F) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - time to maximum concentration (tmax) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - Mean Residence Time (MRT [area]) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Change in LDL-C from baseline [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with Adverse Events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
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

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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hypercholesterolemia
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) - 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2013
May 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France,   Moldova, Republic of
 
NCT01670734
POP12671, 2012-002292-33, U1111-1129-0248
No
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
June 2013

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