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

This study is currently recruiting participants.
Verified March 2013 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01670734
First received: August 16, 2012
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

Primary Objective:

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

Secondary Objectives:

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

Condition Intervention Phase
Hypercholesterolemia
 Drug: SAR236553 (REGN727)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pharmacokinetics: Assessment of serum concentrations of SAR236553 (REGN727) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: September 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR236553 (REGN727) - mild hepatic function
Injection through subcutaneous (SC) administration in patients with mild hepatic function
 Drug: SAR236553 (REGN727)

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

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

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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670734

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
France
Investigational Site Number 250001 Active, not recruiting
Rennes, France, 35000
Moldova, Republic of
Investigational Site Number 498001 Recruiting
Chisinau, Moldova, Republic of, 2025
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01670734     History of Changes
Other Study ID Numbers: POP12671, 2012-002292-33, U1111-1129-0248
Study First Received: August 16, 2012
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Liver Diseases
Hyperlipidemias
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013