Liver DiseasePhase 1NCT00829231
Hepatic Impairment Study
A Phase 1 study testing Sorafenib (Nexavar, BAY43-9006) in people with Liver Disease, run by Bayer at 3 sites in United States.
Trial summary
This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Disease
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to Jul 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Knoxville, Tennessee, 37920
Study site
Miami, Florida, 33014
Study site
Orlando, Florida, 32809
About this study
Official title: Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)
This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.
- Conditions
- Liver Disease
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Liver disease
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
Mildly Hepatic Impaired Subjects
Sorafenib (Nexavar, BAY43-9006)Drug
Moderately Hepatic Impaired Subjects
Sorafenib (Nexavar, BAY43-9006)Drug
Healthy Subjects
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
| Arm 2 | Experimental | Not described Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
| Arm 3 | Experimental | Not described Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK measurements
Measured: Day 1-6
Secondary outcomes (5)
Physical Exam
Measured: Screening, Day 6
Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis
Measured: Screening Day 1, Day 6
ECG
Measured: Screening Day 1, Day 6
Vital Signs
Measured: Screening Day 1, Day 6
Follow up phone call
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829231
- Sponsor's protocol ID
- 12349
- Status last verified
- Oct 2014
- First submitted
- 23 Jan 2009
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)
- ClinicalTrials.gov ID
- NCT00829231
- Acronym / sponsor ID
- 12349
- Conditions
- Liver Disease
- Keywords
- Liver disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 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.
This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sorafenib (Nexavar, BAY43-9006) |
| Arm 2 | Experimental | Drug: Sorafenib (Nexavar, BAY43-9006) |
| Arm 3 | Experimental | Drug: Sorafenib (Nexavar, BAY43-9006) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)Mildly Hepatic Impaired Subjects | Drug | Arm 1 |
| Sorafenib (Nexavar, BAY43-9006)Moderately Hepatic Impaired Subjects | Drug | Arm 2 |
| Sorafenib (Nexavar, BAY43-9006)Healthy Subjects | Drug | Arm 3 |
Primary outcome
PK measurements
Time frame: Day 1-6
5 secondary outcomes
Physical Exam
Time frame: Screening, Day 6
Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis
Time frame: Screening Day 1, Day 6
ECG
Time frame: Screening Day 1, Day 6
Vital Signs
Time frame: Screening Day 1, Day 6
Follow up phone call
Time frame: Day 14
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 3 Nov 2014.
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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.
Bayer Study Director study director
Bayer
3 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 Sorafenib (Nexavar, BAY43-9006) in people with Liver Disease, run by Bayer at 3 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 1 inclusion and 0 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 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
PK measurements (time frame: Day 1-6). 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 3 Nov 2014.