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NCT03471871 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea

A Phase 1 study of Obstructive Sleep Apnea and Healthy Subjects, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
146
Enrollment target
11
Study locations

NCT03471871 is a Phase 1 study of Obstructive Sleep Apnea and Healthy Subjects that has completed, run by Eisai. The registered enrollment target is 146 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (34% lower). The trial reports 11 study locations across 7 states.

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The verdict

NCT03471871, a Phase 1 study of Obstructive Sleep Apnea and Healthy Subjects, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 1
Development phase
146 participants
Enrollment target
11
Study locations

Study Summary

This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment and to determine whether it increases the apnea-hypopnea index after single and multiple doses of treatment in adult and elderly participants with mild obstructive sleep apnea (OSA).

Conditions Studied

Obstructive Sleep Apnea Healthy Subjects

Interventions

  • DRUG Placebo
  • DRUG Lemborexant 10 mg
  • DRUG Lemborexant 25 mg

Study Locations (11)

Arizona

  • PACT - Glendale
  • Pulmonary Associates, PA - Phoenix

Florida

  • PAB Clinical Research - Brandon
  • Research Centers of America - Hollywood

Maryland

  • The Center for Sleep & Wake Disorders - Chevy Chase
  • Advarra - Columbia

Ohio

  • CTI Clinical Research Center - Cincinnati
  • Community Research - Cincinnati

California

  • Pacific Research Network. LLC - San Diego

Georgia

  • Neurotrials Research, Inc - Atlanta

New York

  • Clinilabs Drug Development - New York

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2018-02-21
Est. Completion 2018-08-03
Phase Phase 1

Sponsor

Eisai

287 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03471871

The ClinicalTrials.gov registry entry for NCT03471871 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (34% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03471871 reports 11 study locations spanning 7 distinct geographic areas - top geographies include Arizona, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT03471871 about?

NCT03471871 is a clinical study titled "Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea". This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment and to determine whether it increases the apnea-hypopnea index after sing...

What is the current status of trial NCT03471871?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2018-02-21. Estimated completion is 2018-08-03.

What conditions does trial NCT03471871 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea, Healthy Subjects.

What interventions are being tested in trial NCT03471871?

The interventions under investigation include: Placebo (DRUG), Lemborexant 10 mg (DRUG), Lemborexant 25 mg (DRUG).

Who is sponsoring clinical trial NCT03471871?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03471871 being conducted?

This trial has 11 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.