Severe Hepatic Impairment Clinical Trial
Official title:
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03664544 -
PK Study in Subjects With Severe Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT05116826 -
Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients
|
Phase 1 | |
| Completed |
NCT05199610 -
An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143
|
Phase 1 | |
| Terminated |
NCT03818672 -
Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
|
Phase 4 | |
| Completed |
NCT02138162 -
A Study to Investigate the Effect of Severely Diminished Liver Function on the Metabolism, Safety, and Tolerability of a Single Oral Dose of Enzalutamide in Men
|
Phase 1 | |
| Completed |
NCT03865446 -
Evaluate Severe Hepatic Impairment on Dacomitinib PK
|
Phase 1 | |
| Recruiting |
NCT05224609 -
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
|
Phase 1 |