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History of Changes for Study: NCT01670734
Pharmacokinetic and Tolerability of SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Latest version (submitted June 27, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 20, 2012 None (earliest Version on record)
2 October 24, 2012 Recruitment Status, Study Status and Contacts/Locations
3 January 3, 2013 Study Status, Contacts/Locations and Study Identification
4 March 14, 2013 Study Status and Contacts/Locations
5 June 11, 2013 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 June 27, 2013 Arms and Interventions, Outcome Measures, Study Description, Study Status and Study Identification
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Study NCT01670734
Submitted Date:  August 20, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: POP12671
Brief Title: Pharmacokinetic and Tolerability of SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
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
Secondary IDs: 2012-002292-33
U1111-1129-0248 [UTN]
Open or close this module Study Status
Record Verification: August 2012
Overall Status: Not yet recruiting
Study Start: September 2012
Primary Completion: August 2013 [Anticipated]
Study Completion: August 2013 [Anticipated]
First Submitted: August 16, 2012
First Submitted that
Met QC Criteria:
August 20, 2012
First Posted: August 22, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 20, 2012
Last Update Posted: August 22, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party: Sponsor
Collaborators: Regeneron Pharmaceuticals
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

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.
Detailed Description: Total duration of the study per subject (excluding screening) is about 12 weeks.
Open or close this module Conditions
Conditions: Hypercholesterolemia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
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

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Pharmacokinetics: Assessment of serum concentrations of 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: Trial Transparency Team
Email: Contact-US@sanofi-aventis.com
Study Officials: Clinical Sciences & Operations
Study Director
Sanofi
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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