Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01271387
• Date of registration: 05/01/2011
• Primary sponsor: Vanda Pharmaceuticals
• Public title: Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment
• Scientific title: An Open-Label, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetics of Tasimelteon With That in Matched Healthy Control Subjects
• Date of first enrolment: January 2011
• Target sample size: 29
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01271387
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Countries of recruitment

United States

Contacts

• Name: Vanda Pharmaceuticals
• Affiliation: Vanda Pharmaceuticals

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatic Impairment

Intervention(s)

Drug: tasimelteon

Primary Outcome(s)

Plasma concentrations and PK of tasimelteon [Time Frame: 36 hours]

Secondary Outcome(s)

Plasma concentrations and PK of tasimelteon metabolites [Time Frame: 36 hours]

Safety [Time Frame: 36 hours]

Secondary ID(s)

VP-VEC-162-1105

Source(s) of Monetary Support

Please refer to primary and secondary sponsors