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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670734
• Other study ID #: POP12671
• Secondary ID: 2012-002292-33U1
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2012
• Last updated: June 27, 2013
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
France	Investigational Site Number 250001	Rennes
Moldova, Republic of	Investigational Site Number 498001	Chisinau

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

France,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)		Up to 12 weeks	No
Secondary	Assessment of PK parameter - terminal elimination half-life (t1/2z) [		Up to 12 weeks	No
Secondary	Assessment of PK parameter - apparent total body clearance (CL/F)		Up to 12 weeks	No
Secondary	Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)		Up to 12 weeks	No
Secondary	Assessment of PK parameter - time to maximum concentration (tmax)		Up to 12 weeks	No
Secondary	Assessment of PK parameter - Mean Residence Time (MRT [area])		Up to 12 weeks	No
Secondary	Pharmacodynamics: Change in LDL-C from baseline		Up to 12 weeks	No
Secondary	Number of participants with Adverse Events		Up to 12 weeks	Yes