- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01670734
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Rennes, France, 35000
- Investigational Site Number 250001
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-
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Chisinau, Moldova, Republic of, 2025
- Investigational Site Number 498001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: alirocumab SAR236553 (REGN727) - mild hepatic function
Injection through subcutaneous (SC) administration in patients with mild hepatic function
|
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 |
EXPERIMENTAL: alirocumab SAR236553 (REGN727) - moderate hepatic function
Injection through subcutaneous (SC) administration in patients with moderate hepatic function
|
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 |
EXPERIMENTAL: alirocumab SAR236553 (REGN727) - normal hepatic function
Injection through subcutaneous (SC) administration in patients with normal hepatic function
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of PK parameter - time to maximum concentration (tmax)
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Pharmacodynamics: Change in LDL-C from baseline
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Number of participants with Adverse Events
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Assessment of PK parameter - terminal elimination half-life (t1/2z) [
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Assessment of PK parameter - apparent total body clearance (CL/F)
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Assessment of PK parameter - Mean Residence Time (MRT [area])
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POP12671
- 2012-002292-33
- U1111-1129-0248 (OTHER: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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