Hepatic ImpairmentPhase 1NCT01271387
Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment
A Phase 1 study testing tasimelteon in people with Hepatic Impairment, run by Vanda Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to individuals who have normal liver 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?
- tasimelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2011
- 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
- All Subjects:
- Ability and acceptance to provide written informed consent;
- Men or women between 18 - 75 years, inclusive;
- Subjects with Body Mass Index (BMI) of >18 and <35 kg/m2;
- Women of child-bearing potential must be using an acceptable method of birth control;
- Willing and able to comply with study requirements and restrictions;
Show all 13Show fewer
- Subjects with mild or moderate hepatic impairment:
- Stable hepatic impairment satisfying the criteria for Class A or B of the modified Child-Pugh classification documented by medical history;
- Subjects with Moderate hepatic impairment must also have either liver cirrhosis or physical signs consistent with a clinical diagnosis of liver cirrhosis
- Creatinine clearance greater than 50 mL/min
- Healthy matched controls:
- Matched to subjects with hepatic impairment by gender, age, BMI, and smoking status
- Good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests, vital signs and urinalysis;
Who cannot join
- Smokers unable or unwilling to limit consumption;
- Exposure to any investigational drug, including placebo, within 30 days of dosing;
- Blood Donation or loss of 400 mL or more within two months prior to dosing;
- Significant illness within the two weeks prior to dosing;
- History of autonomic dysfunction;
- History of acute or chronic bronchospastic disease, including asthma and chronic obstructive pulmonary disease, treated or not treated;
Show all 22Show fewer
- A known hypersensitivity to tasimelteon or drugs similar to tasimelteon including melatonin;
- Pregnant or lactating females;
- History of drug or alcohol abuse within the 12 months prior to screening
- History of immunocompromise, including a positive HIV (ELISA and Western blot) test result;
- Any surgical or medical condition which might significantly alter the absorption, distribution or excretion of any drug;
- Clinically significant ECG abnormalities or vital sign abnormalities at screening or a history of unstable, severe, or clinically significant cardiovascular disease;
- Subjects with mild or moderate hepatic impairment:
- Clinically significant abnormal findings, not consistent with clinical disease, upon physical examination, ECG, or laboratory evaluation;
- Current symptoms or past history (within the last 6 months) of encephalopathy;
- Severe ascites;
- Previous surgical porto-systemic shunt including transjugular intrahepatic portosystemic shunt (TIPS);
- Progressive liver disease within 4 weeks prior to screening.
- Healthy matched controls:
- Use of any prescription medication within 1 month of dosing, and OTC medication within 14 days prior to dosing;
- History or presence of liver disease or liver injury;
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon With That in Matched Healthy Control Subjects
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to individuals who have normal liver function.
Read the detailed description
The study will employ an open-label, parallel-group design. Up to 32 subjects will be enrolled in 3 groups: Group 1 will consist of 8 subjects with mild hepatic impairment; Group 2 will consist of 8 subjects with moderate hepatic impairment; Group 3 will consist of up to 16 healthy subjects matched by gender, age, smoking status, and body mass index, to Groups 1 and/or 2. For each group, there will be a 21-day screening period, a baseline period, a single-dose treatment period with an on-site observation period of 36 hours, and a study completion evaluation conducted after the last PK blood sample is drawn. Each subject will receive a single 20-mg dose of tasimelteon, after which safety assessments will be performed.
- Conditions
- Hepatic Impairment
- Being tested
- tasimelteon
- Keywords
- Liver disease, pharmacokinetics
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tasimelteonDrug
Also called VEC-162, BMS-214778
20 mg tasimelteon capsules, PO single dose
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: tasimelteon |
| Mild Hepatic Impairment | Experimental | Not described Receives: Drug: tasimelteon |
| Healthy Volunteers | Experimental | Not described Receives: Drug: tasimelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations and PK of tasimelteon
To assess plasma concentrations and pharmacokinetics of tasimelteon in subjects with mild or moderate hepatic impairment compared to healthy subjects with normal hepatic function.
Measured: 36 hours
Secondary outcomes (2)
Plasma concentrations and PK of tasimelteon metabolites
To assess plasma concentrations and pharmacokinetics of tasimelteon metabolites in subjects with mild or moderate hepatic impairment compared to healthy subjects with normal hepatic function.
Measured: 36 hours
Safety
To assess the safety and tolerability of a single 20-mg oral dose of tasimelteon.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
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.
- More trials run by Vanda PharmaceuticalsThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanda Pharmaceuticals, Study director, Vanda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271387
- Sponsor's protocol ID
- VP-VEC-162-1105
- Status last verified
- Feb 2014
- First submitted
- 5 Jan 2011
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon With That in Matched Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT01271387
- Acronym / sponsor ID
- VP-VEC-162-1105
- Conditions
- Hepatic Impairment
- Keywords
- Liver disease, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Jan 2011 (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 purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to individuals who have normal liver function.
Detailed description
The study will employ an open-label, parallel-group design. Up to 32 subjects will be enrolled in 3 groups: Group 1 will consist of 8 subjects with mild hepatic impairment; Group 2 will consist of 8 subjects with moderate hepatic impairment; Group 3 will consist of up to 16 healthy subjects matched by gender, age, smoking status, and body mass index, to Groups 1 and/or 2. For each group, there will be a 21-day screening period, a baseline period, a single-dose treatment period with an on-site observation period of 36 hours, and a study completion evaluation conducted after the last PK blood sample is drawn. Each subject will receive a single 20-mg dose of tasimelteon, after which safety assessments will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Drug: tasimelteon |
| Mild Hepatic Impairment | Experimental | Drug: tasimelteon |
| Healthy Volunteers | Experimental | Drug: tasimelteon |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ability and acceptance to provide written informed consent;
- Men or women between 18 - 75 years, inclusive;
- Subjects with Body Mass Index (BMI) of >18 and <35 kg/m2;
- Women of child-bearing potential must be using an acceptable method of birth control;
- Willing and able to comply with study requirements and restrictions;
Key exclusion criteria (22 listed)
- Smokers unable or unwilling to limit consumption;
- Exposure to any investigational drug, including placebo, within 30 days of dosing;
- Blood Donation or loss of 400 mL or more within two months prior to dosing;
- Significant illness within the two weeks prior to dosing;
- History of autonomic dysfunction;
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 |
|---|---|---|
| tasimelteonAlso: VEC-162, BMS-21477820 mg tasimelteon capsules, PO single dose | Drug | Healthy Volunteers, Mild Hepatic Impairment, Moderate Hepatic Impairment |
Primary outcome
Plasma concentrations and PK of tasimelteon
Time frame: 36 hours
To assess plasma concentrations and pharmacokinetics of tasimelteon in subjects with mild or moderate hepatic impairment compared to healthy subjects with normal hepatic function.
2 secondary outcomes
Plasma concentrations and PK of tasimelteon metabolites
Time frame: 36 hours
Safety
Time frame: 36 hours
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 17 Feb 2014.
Related trials for Hepatic Impairment
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
Vanda Pharmaceuticals study director
Vanda Pharmaceuticals
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 tasimelteon in people with Hepatic Impairment, run by Vanda Pharmaceuticals at 1 site 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 13 inclusion and 22 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 17 Feb 2014. 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 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?
Plasma concentrations and PK of tasimelteon (time frame: 36 hours). 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 17 Feb 2014.