Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment
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ClinicalTrials.gov Identifier: NCT01271387 |
Recruitment Status :
Completed
First Posted : January 6, 2011
Last Update Posted : February 17, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatic Impairment | Drug: tasimelteon | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon With That in Matched Healthy Control Subjects |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Moderate Hepatic Impairment |
Drug: tasimelteon
20 mg tasimelteon capsules, PO single dose
Other Names:
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Experimental: Mild Hepatic Impairment |
Drug: tasimelteon
20 mg tasimelteon capsules, PO single dose
Other Names:
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Experimental: Healthy Volunteers |
Drug: tasimelteon
20 mg tasimelteon capsules, PO single dose
Other Names:
|
- 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.
- Plasma concentrations and PK of tasimelteon metabolites [ Time Frame: 36 hours ]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.
- Safety [ Time Frame: 36 hours ]To assess the safety and tolerability of a single 20-mg oral dose of tasimelteon.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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;
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;
Exclusion Criteria:
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271387
United States, Florida | |
Orlando Clinical Research Center | |
Orlando, Florida, United States, 32809 |
Study Director: | Vanda Pharmaceuticals | Vanda Pharmaceuticals |
Responsible Party: | Vanda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01271387 |
Other Study ID Numbers: |
VP-VEC-162-1105 |
First Posted: | January 6, 2011 Key Record Dates |
Last Update Posted: | February 17, 2014 |
Last Verified: | February 2014 |
Liver disease pharmacokinetics |
Liver Diseases Digestive System Diseases |