CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 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.

Search/NCT03443063
NCT03443063Phase 1Completed
CompareCT.gov

An Open-label, Parallel-Group Study to Evaluate the Pharmacokinetics of Lemborexant and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment

Eisai Inc.·interventional·Posted Feb 22, 2018·Updated Mar 12, 2020

In Brief

A Phase 1 clinical trial evaluating Lemborexant for Renal Impairment. Completed, enrolled 16 participants across 2 sites.

Detailed Summary

This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Impairment
CountriesUnited States
CollaboratorsPurdue Pharma LP

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedFeb 22, 2018
Enrollment StartFeb 7, 2018
Primary CompletionAug 24, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.4 years ago

Interventions

Lemborexantdrug

oral tablet