Conditions: Severe Hepatic Impairment
Keywords: Drug therapy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function. arm 2: Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.

Interventions: intervention 1: Vortioxetine
Intervention descriptions: intervention 1: Vortioxetine tablets

Protocol document: