Clinical trial NCT01670734: Pharmacokinetic and Tolerability of Alirocumab 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-08-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Assessment of PK parameter - terminal elimination half-life (t1/2z) [
timeFrame: Up to 12 weeks
measure: Assessment of PK parameter - apparent total body clearance (CL/F)
timeFrame: Up to 12 weeks
measure: Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)
timeFrame: Up to 12 weeks
measure: Assessment of PK parameter - time to maximum concentration (tmax)
timeFrame: Up to 12 weeks
measure: Assessment of PK parameter - Mean Residence Time (MRT [area])
timeFrame: Up to 12 weeks
measure: Pharmacodynamics: Change in LDL-C from baseline
timeFrame: Up to 12 weeks
measure: Number of participants with Adverse Events
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Rennes
country: France
facility: Investigational Site Number 250001
city: Chisinau
country: Moldova, Republic of
facility: Investigational Site Number 498001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: