NCT02170220

Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment

A Phase 1, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Oral Dose of 5 mg Vortioxetine in Subjects With Normal Hepatic Function or Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic impairment compared to healthy participants.

Detailed description

The drug being tested in this study is called vortioxetine. Vortioxetine is being tested to assess how it moves throughout the body in people with severe hepatic impairment compared to people with normal hepatic function. This study looked at lab results in people who took vortioxetine. The study enrolled 12 participants. Participants were assigned to one of the two treatment groups based on their hepatic function (severe hepatic impairment vs. normal hepatic function). All participants in both groups will receive one vortioxetine 5-mg tablet. This single-center trial was conducted in the United States. The overall time to participate in this study was up to 58 days. Participants made 2 visits to the clinic, including one 12-day period of confinement to the clinic, and were contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Conditions

• Severe Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Vortioxetine	Vortioxetine tablets

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-06-23
• Last updated: 2016-01-05
• Results posted: 2016-01-05

Locations

1 site across 1 country: United States