At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Lemborexantdrug
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.
An Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Lemborexant for Hepatic Impairment. Completed, enrolled 24 participants across 2 sites.
Detailed Summary
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesUnited States
CollaboratorsPurdue Pharma LP
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedFeb 2018
Primary CompletionApr 2018
TodayJul 2026
First PostedFeb 22, 2018
Enrollment StartJan 26, 2018
Primary CompletionApr 23, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.4 years ago
Interventions
Lemborexantdrug
oral tablet