Hepatic FailurePhase 1NCT00831532
Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function
A Phase 1 study testing Dimebon in people with Hepatic Failure, run by Pfizer at 2 sites in United States.
Trial summary
1. To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function. 2. To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and subjects with normal hepatic function. 3. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Failure
- What is being tested?
- Dimebon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (healthy is defined as the absence of clinically-relevant abnormalities identified by a detailed medical history, full physical examination, 12-lead ECG and clinical laboratory tests).
- Free of any medical or surgical conditions that might significantly interfere with gastrointestinal absorption, distribution, metabolism, or excretion of Dimebon.
- Demographically comparable to subjects with mild and moderate hepatic impairment.
- Subjects with hepatic impairment: Screening medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests performed within 28 days before the first dose of study medication, abnormal findings that are related to the subject's underlying condition are acceptable.
- Satisfy the criteria for Class A, B, or C of the modified Child-Pugh classification [Mild (Child-Pugh Scores 5-6 points), moderate (Child-Pugh Scores 7-9 points), and severe (Child-Pugh Scores >9 and <12 points)] within 14 days before the first dose of study medication.
- A diagnosis of hepatic impairment due to cirrhosis, not secondary to other diseases, which is confirmed and documented by medical history, physical examination, liver biopsy or hepatic ultrasound, CT scan or MRI.
Who cannot join
- Subjects presenting with any of the following will not be included in the trial:CYP2D6 PM genotype, as identified by screening genotyping.
- A known sensitivity to Dimebon.
- Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
- History of febrile illness within 5 days prior to the first dose.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function
- To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function.
- To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and subjects with normal hepatic function.
- To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic function.
- Conditions
- Hepatic Failure
- Being tested
- Dimebon
- Keywords
- Dimebon Hepatic Impairment
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimebonDrug
Dimebon 5mg in healthy controls
DimebonDrug
Dimebon 5mg in mild hepatic impairment patients
DimebonDrug
Dimebon 5mg in moderate hepatic impairment patients
DimebonDrug
Dimebon 5mg in Severe Hepatic Impairment
| Study group | Role | What they receive |
|---|---|---|
| Normal | Experimental | Healthy Volunteers Receives: Drug: Dimebon |
| Mild Hepatic Impairment | Experimental | Mild hepatic impairment patients Receives: Drug: Dimebon |
| Moderate hepatic Impairment | Experimental | Moderate Hepatic Impairment Patients Receives: Drug: Dimebon |
| Severe Hepatic Impairment | Experimental | Severe Hepatic Impairment Patients Receives: Drug: Dimebon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (AUC and Cmax)
Measured: 1 day
Secondary outcomes (1)
Safety (AEs, labs, ECG, vitals)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic FailureStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831532
- Sponsor's protocol ID
- B1451018
- Status last verified
- Sep 2009
- First submitted
- 20 Jan 2009
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT00831532
- Acronym / sponsor ID
- B1451018
- Conditions
- Hepatic Failure
- Keywords
- Dimebon Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 29 Jan 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.
- To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function.
- To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and subjects with normal hepatic function.
- To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal | Experimental | Drug: DimebonHealthy Volunteers |
| Mild Hepatic Impairment | Experimental | Drug: DimebonMild hepatic impairment patients |
| Moderate hepatic Impairment | Experimental | Drug: DimebonModerate Hepatic Impairment Patients |
| Severe Hepatic Impairment | Experimental | Drug: DimebonSevere Hepatic Impairment Patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy (healthy is defined as the absence of clinically-relevant abnormalities identified by a detailed medical history, full physical examination, 12-lead ECG and clinical laboratory tests).
- Free of any medical or surgical conditions that might significantly interfere with gastrointestinal absorption, distribution, metabolism, or excretion of Dimebon.
- Demographically comparable to subjects with mild and moderate hepatic impairment.
- Subjects with hepatic impairment: Screening medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests performed within 28 days before the first dose of study medication, abnormal findings that are related to the subject's underlying condition are acceptable.
- Satisfy the criteria for Class A, B, or C of the modified Child-Pugh classification [Mild (Child-Pugh Scores 5-6 points), moderate (Child-Pugh Scores 7-9 points), and severe (Child-Pugh Scores >9 and <12 points)] within 14 days before the first dose of study medication.
Key exclusion criteria (5 listed)
- Subjects presenting with any of the following will not be included in the trial:CYP2D6 PM genotype, as identified by screening genotyping.
- A known sensitivity to Dimebon.
- Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
- History of febrile illness within 5 days prior to the first dose.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
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 |
|---|---|---|
| DimebonDimebon 5mg in healthy controls | Drug | Normal |
| DimebonDimebon 5mg in mild hepatic impairment patients | Drug | Mild Hepatic Impairment |
| DimebonDimebon 5mg in moderate hepatic impairment patients | Drug | Moderate hepatic Impairment |
| DimebonDimebon 5mg in Severe Hepatic Impairment | Drug | Severe Hepatic Impairment |
Primary outcome
Pharmacokinetics (AUC and Cmax)
Time frame: 1 day
1 secondary outcome
Safety (AEs, labs, ECG, vitals)
Time frame: 1 day
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 16 Sep 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Hepatic Failure
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dimebon in people with Hepatic Failure, run by Pfizer at 2 sites in United States.
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 6 inclusion and 5 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 16 Sep 2009. 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 United States. 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 (AUC and Cmax) (time frame: 1 day). 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 16 Sep 2009.