At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Vortioxetinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Vortioxetine for Severe Hepatic Impairment. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hepatic Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJul 2014
Primary CompletionNov 2014
Study CompletionDec 2014
TodayJul 2026
First PostedJun 23, 2014
Enrollment StartJul 1, 2014
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.0 years ago
Interventions
Vortioxetinedrug
Vortioxetine tablets