Hepatic Impairment; Renal ImpairmentEarly Phase 1NCT02998775
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
A Early Phase 1 study testing Plasma Sampling in people with Hepatic Impairment; Renal Impairment, run by Eisai Inc. at 3 sites in United States.
Trial summary
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. The primary objective of the study is to obtain plasma from participants for use in in vitro protein binding studies. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment; Renal Impairment
- What is being tested?
- Plasma Sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Dec 2016to 8 Jul 2017
- Phase
- Early 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Age, at the time of Informed Consent:
- Hepatic Impairment Participants (Including Matched Healthy Participants): 18 to 70 years old, inclusive ii. Renal Impairment Participants (Including Matched Healthy Participants): 18 to 79 years old, inclusive
- Non-smokers and smokers who smoke no more than 10 cigarettes per day
- Besides diabetes and, as appropriate, renal or hepatic impairment, participants must have no history of acute or chronic clinically relevant disease or condition, as determined by the investigator.
- For participants with hepatic impairment:
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- Liver cirrhosis that has been stable;
- Platelet count >30,000 cells/millimeter cubed (mm^3);
- Total score on the Child-Pugh classification system between 5 and 6 (Group 1, mild), 7 and 9 (Group 2, moderate), and 10 and 15 (Group 3, severe)
- For healthy participants:
- Creatinine clearance ≥ 81 milliliter per minute (mL/min)
- For participants with renal impairment:
- Must have a diagnosis of renal impairment that has been stable
- Must have renal impairment in the following categories based on creatinine clearance values: mild (creatinine clearance, 50 to 80 mL/min), moderate (creatinine clearance, 30 to 49 mL/min), or severe (creatinine clearance, 15 to 29 mL/min) renal impairment
Who cannot join
- Use of any new medication
- Human immunodeficiency virus (HIV) positive
- Presence of acute active liver disease or acute liver injury
- History of significant cardiovascular impairment
- Positive drug or alcohol test
- Weight loss or gain of >10% prior to Day 1
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- Receipt of blood or blood products or donation of blood or blood products
- For participants with hepatic impairment:
- History of hepatic transplant, systemic lupus erythematosus, or hepatic coma
- Received treatment with interferon or pegylated interferon
- Participants who have encephalopathy >Grade 2, sepsis, or gastrointestinal bleeding; esophageal varices >Grade 2, acute hepatic failure of any etiology, history of surgical portosystemic shunt, renal impairment (creatinine clearance <50 mL/min according to the Cockcroft-Gault formula), and rapidly deteriorating hepatic function
- Systolic blood pressure (SBP) ≥ 160 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) ≥ 100 mmHg
- For healthy participants:
- Hemoglobin level less than 12.0 grams per deciliter (g/dL)
- For participants with renal impairment:
- A history of renal transplant
- SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg for participants with mild renal impairment; SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg for participants with moderate and severe renal impairment
- Significant bleeding diathesis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Orleans Center for Clinical Research
Knoxville, Tennessee
DaVita Clinical Research
Minneapolis, Minnesota
Orlando Clinical Research Center, Inc.
Orlando, Florida
About this study
Official title: A Multicenter Phase 0 Study In Healthy Subjects and Subjects With Either Hepatic Or Renal Impairment To Obtain Plasma For Assessment In Vitro Lenvatinib Protein Binding
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. The primary objective of the study is to obtain plasma from participants for use in in vitro protein binding studies.
Read the detailed description
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. Approximately 6 participants with each degree (mild, moderate, or severe) of hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be enrolled. One cohort of healthy participants will be matched to the hepatic-impaired participants, whereas the other will be matched to the renal-impaired participants.
The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered in this study.
The end of the study will be the date of the last study visit for the last participant in the study.
The following estimates are provided:
- From first participant in to last participant out, the study is expected to take approximately one year to complete.
- The maximum estimated duration of the study for each participant is anticipated to be approximately 5 weeks.
- Conditions
- Hepatic Impairment; Renal Impairment
- Being tested
- Plasma Sampling
- Keywords
- in vitro protein binding, hepatic impairment, renal impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma SamplingDrug
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
| Study group | Role | What they receive |
|---|---|---|
| 6 participants with mild renal impairment | Other | Renal Impairment Mild: creatinine clearance, 50 to 80 milliliters per minute (mL/min) Receives: Drug: Plasma Sampling |
| 6 participants with moderate renal impairment | Other | Renal Impairment Moderate: creatinine clearance, 30 to 49 mL/min Receives: Drug: Plasma Sampling |
| 6 participants with severe renal impairment | Other | Renal Impairment Severe: creatinine clearance, 15 to 29 mL/min Receives: Drug: Plasma Sampling |
| 8 participants normal renal status | Other | Renal status normal as defined by creatinine clearance ≥ 81 mL/min, otherwise age, gender, and smoking characteristics matching renal-impaired participants Receives: Drug: Plasma Sampling |
| 6 participants with mild hepatic impairment | Other | Hepatic impairment mild: total score on the Child-Pugh classification system between 5 and 6 Receives: Drug: Plasma Sampling |
| 6 participants with moderate hepatic impairment | Other | Hepatic impairment moderate: total score on the Child-Pugh classification system between 7 and 9 Receives: Drug: Plasma Sampling |
| 6 participants with severe hepatic impairment | Other | Hepatic impairment severe: total score on the Child-Pugh classification system between 10 and 15 Receives: Drug: Plasma Sampling |
| 8 participants normal hepatic status | Other | Hepatic status normal, otherwise age, gender, and smoking characteristics matching hepatic-impaired participants Receives: Drug: Plasma Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with any serious adverse event and any non-serious adverse event
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start2 Dec 2016
- Primary completion8 Jul 2017
- Study completion8 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Impairment; Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998775
- Sponsor's protocol ID
- E7080-A001-010
- Status last verified
- Sep 2018
- First submitted
- 16 Dec 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 0 Study In Healthy Subjects and Subjects With Either Hepatic Or Renal Impairment To Obtain Plasma For Assessment In Vitro Lenvatinib Protein Binding
- ClinicalTrials.gov ID
- NCT02998775
- Acronym / sponsor ID
- E7080-A001-010
- Conditions
- Hepatic Impairment; Renal Impairment
- Keywords
- in vitro protein binding, hepatic impairment, renal impairment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 8 Jul 2017 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 20 Dec 2016 (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.
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. The primary objective of the study is to obtain plasma from participants for use in in vitro protein binding studies.
Detailed description
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. Approximately 6 participants with each degree (mild, moderate, or severe) of hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be enrolled. One cohort of healthy participants will be matched to the hepatic-impaired participants, whereas the other will be matched to the renal-impaired participants.
The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered in this study.
The end of the study will be the date of the last study visit for the last participant in the study.
The following estimates are provided:
- From first participant in to last participant out, the study is expected to take approximately one year to complete.
- The maximum estimated duration of the study for each participant is anticipated to be approximately 5 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 6 participants with mild renal impairment | Other | Drug: Plasma SamplingRenal Impairment Mild: creatinine clearance, 50 to 80 milliliters per minute (mL/min) |
| 6 participants with moderate renal impairment | Other | Drug: Plasma SamplingRenal Impairment Moderate: creatinine clearance, 30 to 49 mL/min |
| 6 participants with severe renal impairment | Other | Drug: Plasma SamplingRenal Impairment Severe: creatinine clearance, 15 to 29 mL/min |
| 8 participants normal renal status | Other | Drug: Plasma SamplingRenal status normal as defined by creatinine clearance ≥ 81 mL/min, otherwise age, gender, and smoking characteristics matching renal-impaired participants |
| 6 participants with mild hepatic impairment | Other | Drug: Plasma SamplingHepatic impairment mild: total score on the Child-Pugh classification system between 5 and 6 |
| 6 participants with moderate hepatic impairment | Other | Drug: Plasma SamplingHepatic impairment moderate: total score on the Child-Pugh classification system between 7 and 9 |
| 6 participants with severe hepatic impairment | Other | Drug: Plasma SamplingHepatic impairment severe: total score on the Child-Pugh classification system between 10 and 15 |
| 8 participants normal hepatic status | Other | Drug: Plasma SamplingHepatic status normal, otherwise age, gender, and smoking characteristics matching hepatic-impaired participants |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or Female
- Age, at the time of Informed Consent:
- Non-smokers and smokers who smoke no more than 10 cigarettes per day
- Besides diabetes and, as appropriate, renal or hepatic impairment, participants must have no history of acute or chronic clinically relevant disease or condition, as determined by the investigator.
- For participants with hepatic impairment:
Key exclusion criteria (18 listed)
- Use of any new medication
- Human immunodeficiency virus (HIV) positive
- Presence of acute active liver disease or acute liver injury
- History of significant cardiovascular impairment
- Positive drug or alcohol test
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 |
|---|---|---|
| Plasma SamplingNo lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding. | Drug | 6 participants with mild hepatic impairment, 6 participants with mild renal impairment, 6 participants with moderate hepatic impairment, 6 participants with moderate renal impairment, 6 participants with severe hepatic impairment, 6 participants with severe renal impairment, 8 participants normal hepatic status, 8 participants normal renal status |
Primary outcome
Number of participants with any serious adverse event and any non-serious adverse event
Time frame: 1 week
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 7 Sep 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Plasma Sampling in people with Hepatic Impairment; Renal Impairment, run by Eisai Inc. 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 14 inclusion and 18 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 7 Sep 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of participants with any serious adverse event and any non-serious adverse event (time frame: 1 week). 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 7 Sep 2018.