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Completed Phase 1 Interventional Accepts healthy volunteers Results available

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment

ClinicalTrials.gov ID: NCT03443063

Public ClinicalTrials.gov record NCT03443063. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT03443063
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Eisai Inc.
Industry
Enrollment
16 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 79 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 7, 2018 (Actual)
Primary completion
Aug 24, 2018 (Actual)
Completion
Aug 24, 2018 (Actual)
Last update posted
Mar 12, 2020

2018

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Clinical Pharmacology of Miami, LLC Miami Florida 33014 —
Orlando Clinical Research Center Orlando Florida 32809 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03443063, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 12, 2020 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03443063 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →