HypercholesterolemiaPhase 1NCT01670734
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
A Phase 1 study testing alirocumab SAR236553 (REGN727) in people with Hypercholesterolemia, run by Sanofi at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- alirocumab SAR236553 (REGN727)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2012to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the detailed description
Total duration of the study per subject (excluding screening) is about 12 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- alirocumab SAR236553 (REGN727)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alirocumab SAR236553 (REGN727)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| alirocumab SAR236553 (REGN727) - mild hepatic function | Experimental | Injection through subcutaneous (SC) administration in patients with mild hepatic function Receives: Drug: alirocumab SAR236553 (REGN727) |
| alirocumab SAR236553 (REGN727) - moderate hepatic function | Experimental | Injection through subcutaneous (SC) administration in patients with moderate hepatic function Receives: Drug: alirocumab SAR236553 (REGN727) |
| alirocumab SAR236553 (REGN727) - normal hepatic function | Experimental | Injection through subcutaneous (SC) administration in patients with normal hepatic function Receives: Drug: alirocumab SAR236553 (REGN727) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)
Measured: Up to 12 weeks
Secondary outcomes (7)
Assessment of PK parameter - terminal elimination half-life (t1/2z) [
Measured: Up to 12 weeks
Assessment of PK parameter - apparent total body clearance (CL/F)
Measured: Up to 12 weeks
Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)
Measured: Up to 12 weeks
Assessment of PK parameter - time to maximum concentration (tmax)
Measured: Up to 12 weeks
Assessment of PK parameter - Mean Residence Time (MRT [area])
Measured: Up to 12 weeks
Pharmacodynamics: Change in LDL-C from baseline
Measured: Up to 12 weeks
Number of participants with Adverse Events
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670734
- Sponsor's protocol ID
- POP12671
- Other IDs
- 2012-002292-33, U1111-1129-0248
- Status last verified
- Jun 2013
- First submitted
- 16 Aug 2012
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01670734
- Acronym / sponsor ID
- POP12671
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alirocumab SAR236553 (REGN727) - mild hepatic function | Experimental | Drug: alirocumab SAR236553 (REGN727)Injection through subcutaneous (SC) administration in patients with mild hepatic function |
| alirocumab SAR236553 (REGN727) - moderate hepatic function | Experimental | Drug: alirocumab SAR236553 (REGN727)Injection through subcutaneous (SC) administration in patients with moderate hepatic function |
| alirocumab SAR236553 (REGN727) - normal hepatic function | Experimental | Drug: alirocumab SAR236553 (REGN727)Injection through subcutaneous (SC) administration in patients with normal hepatic function |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | alirocumab SAR236553 (REGN727) - mild hepatic function, alirocumab SAR236553 (REGN727) - moderate hepatic function, alirocumab SAR236553 (REGN727) - normal hepatic function |
Primary outcome
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)
Time frame: Up to 12 weeks
7 secondary outcomes
Assessment of PK parameter - terminal elimination half-life (t1/2z) [
Time frame: Up to 12 weeks
Assessment of PK parameter - apparent total body clearance (CL/F)
Time frame: Up to 12 weeks
Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)
Time frame: Up to 12 weeks
Assessment of PK parameter - time to maximum concentration (tmax)
Time frame: Up to 12 weeks
Assessment of PK parameter - Mean Residence Time (MRT [area])
Time frame: Up to 12 weeks
Pharmacodynamics: Change in LDL-C from baseline
Time frame: Up to 12 weeks
Number of participants with Adverse Events
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing alirocumab SAR236553 (REGN727) in people with Hypercholesterolemia, run by Sanofi at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.