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NCT03440424 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
A Phase 1 study of Hepatic Impairment, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT03440424 is a Phase 1 study of Hepatic Impairment that has completed, run by Eisai. The registered enrollment target is 24 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (33% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03440424, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Lemborexant
Study Locations (2)
Florida
- Clinical Pharmacology of Miami, LLC - Miami
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-01-26 |
| Est. Completion | 2018-04-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03440424
The ClinicalTrials.gov registry entry for NCT03440424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (33% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Lemborexant is the first listed.
NCT03440424 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03440424 about?
NCT03440424 is a clinical study titled "Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects". 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.
What is the current status of trial NCT03440424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-01-26. Estimated completion is 2018-04-23.
What conditions does trial NCT03440424 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT03440424?
The interventions under investigation include: Lemborexant (DRUG).
Who is sponsoring clinical trial NCT03440424?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03440424 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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