Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

NCT01271387 | Completed Phase 1

• 1 other identifier: VP-VEC-162-1105
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Impairment

Keywords

Liver disease; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  36 hours

Secondary Outcomes (2)

• Plasma concentrations and PK of tasimelteon metabolites

  36 hours

• Safety

  36 hours

Study Arms (3)

Moderate Hepatic Impairment

EXPERIMENTAL

Drug: tasimelteon

Mild Hepatic Impairment

EXPERIMENTAL

Drug: tasimelteon

Healthy Volunteers

EXPERIMENTAL

Drug: tasimelteon

Interventions

tasimelteon DRUG

20 mg tasimelteon capsules, PO single dose

Also known as: VEC-162, BMS-214778

Healthy Volunteers; Mild Hepatic Impairment; Moderate Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

tasimelteon

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Vanda Pharmaceuticals

  Vanda Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

US (1)