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
Verified date | June 2013 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | Investigational Site Number 250001 | Rennes | |
Moldova, Republic of | Investigational Site Number 498001 | Chisinau |
Lead Sponsor | Collaborator |
---|---|
Sanofi | Regeneron Pharmaceuticals |
France, Moldova, Republic of,
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 |
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