MedTrace Logo

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

NCT01271387 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-02-17

No results posted yet for this study

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

Interventions

DRUG

tasimelteon

20 mg tasimelteon capsules, PO single dose

Sponsors & Collaborators

Principal Investigators

  • Vanda Pharmaceuticals · Vanda Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271387 on ClinicalTrials.gov