Hepatic ImpairmentPhase 1NCT01027169
A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics
A Phase 1 study testing safinamide in people with Hepatic Impairment, run by Newron Pharmaceuticals SPA at 1 site in Germany.
Trial summary
The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- safinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Oct 2009
- 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
- Hepatically impaired subjects - Subjects with liver cirrhosis and different degrees of impaired hepatic function: mild and moderate impaired hepatic function (Grade A, or B according to Child-Pugh classification)
- Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, ECG and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to the dosing
- All subject have given written informed consent before any study-related activities are carried out
Who cannot join
- Any clinically relevant disease or condition, which in the Investigator's opinion would exclude the subject from the study
- Diseases or surgeries of the gastrointestinal tract, which could influence the gastro-intestinal absorption and/or motility
- Hepatically impaired subjects - Subjects with primary biliary liver cirrhosis, hepatic encephalopathy grade III and IV, sepsis or spontaneous bacterial peritonitis, gastrointestinal bleeding within one month before the study, esophagus varices > grade II, acute hepatic failure of any aetiology, portosystemic shunt, renal impairment (creatinine clearance < 50 mL/min calculated by use of Cockroft Gault formula)
- Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to the drug administration, or within six times the elimination half-life, whichever is longest, except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Parallel-group, Single Centre, Single Oral Dose Study to Investigate the Pharmacokinetics of 50 mg Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Matched Subjects With Normal Hepatic Function
The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- safinamide
- Keywords
- Hepatic impairment, Liver diseases, Pharmacokinetics, To Investigate Pharmacokinetics of Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Healthy Subjects With Normal Hepatic Function
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safinamideDrug
single dose of 50mg safinamide on Day 1
safinamideDrug
single dose of 50mg safinamide on Day 1
safinamideDrug
single dose of 50mg safinamide on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | subjects with mild hepatic impairment Receives: Drug: safinamide |
| Arm 2 | Experimental | subjects with moderate hepatic impairment Receives: Drug: safinamide |
| Arm 3 | Experimental | matched subjects with normal hepatic function Receives: Drug: safinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of safinamide after single dose administration (Cmax)
Measured: 10 days
Pharmacokinetics of safinamide after single dose administration (AUC)
Measured: 10 days
Secondary outcomes (5)
Safety and tolerability after single dose administration of safinamide (Adverse Events)
Measured: 12 days
Pharmacokinetics of safinamide metabolite NW1153 (Cmax)
Measured: 10 days
Pharmacokinetics of safinamide metabolite NW1153 (AUC)
Measured: 10 days
Pharmacokinetics of safinamide metabolite NW1689 (Cmax)
Measured: 10 days
Pharmacokinetics of safinamide metabolite NW1689 (AUC)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atef Halabi, MD, Principal investigator, CRS Clinical Research Services Kiel GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027169
- Sponsor's protocol ID
- 28696
- Status last verified
- Aug 2011
- First submitted
- 3 Dec 2009
- Last updated
- 29 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel-group, Single Centre, Single Oral Dose Study to Investigate the Pharmacokinetics of 50 mg Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Matched Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT01027169
- Acronym / sponsor ID
- 28696
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic impairment, Liver diseases, Pharmacokinetics, To Investigate Pharmacokinetics of Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Healthy Subjects With Normal Hepatic Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- First posted
- 7 Dec 2009 (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.
The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: safinamidesubjects with mild hepatic impairment |
| Arm 2 | Experimental | Drug: safinamidesubjects with moderate hepatic impairment |
| Arm 3 | Experimental | Drug: safinamidematched subjects 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)
- Hepatically impaired subjects - Subjects with liver cirrhosis and different degrees of impaired hepatic function: mild and moderate impaired hepatic function (Grade A, or B according to Child-Pugh classification)
- Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, ECG and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to the dosing
- All subject have given written informed consent before any study-related activities are carried out
Key exclusion criteria (4 listed)
- Any clinically relevant disease or condition, which in the Investigator's opinion would exclude the subject from the study
- Diseases or surgeries of the gastrointestinal tract, which could influence the gastro-intestinal absorption and/or motility
- Hepatically impaired subjects - Subjects with primary biliary liver cirrhosis, hepatic encephalopathy grade III and IV, sepsis or spontaneous bacterial peritonitis, gastrointestinal bleeding within one month before the study, esophagus varices > grade II, acute hepatic failure of any aetiology, portosystemic shunt, renal impairment (creatinine clearance < 50 mL/min calculated by use of Cockroft Gault formula)
- Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to the drug administration, or within six times the elimination half-life, whichever is longest, except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before study drug administration
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 |
|---|---|---|
| safinamidesingle dose of 50mg safinamide on Day 1 | Drug | Arm 1 |
| safinamidesingle dose of 50mg safinamide on Day 1 | Drug | Arm 2 |
| safinamidesingle dose of 50mg safinamide on Day 1 | Drug | Arm 3 |
Primary outcome
Pharmacokinetics of safinamide after single dose administration (Cmax)
Time frame: 10 days
Pharmacokinetics of safinamide after single dose administration (AUC)
Time frame: 10 days
5 secondary outcomes
Safety and tolerability after single dose administration of safinamide (Adverse Events)
Time frame: 12 days
Pharmacokinetics of safinamide metabolite NW1153 (Cmax)
Time frame: 10 days
Pharmacokinetics of safinamide metabolite NW1153 (AUC)
Time frame: 10 days
Pharmacokinetics of safinamide metabolite NW1689 (Cmax)
Time frame: 10 days
Pharmacokinetics of safinamide metabolite NW1689 (AUC)
Time frame: 10 days
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 29 Mar 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.
Atef Halabi, MD principal investigator
CRS Clinical Research Services Kiel GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing safinamide in people with Hepatic Impairment, run by Newron Pharmaceuticals SPA at 1 site in Germany.
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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 of safinamide after single dose administration (Cmax) (time frame: 10 days). The study lists 2 primary outcomes in all. 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 29 Mar 2013.