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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: Completed Phase 1 study of Hepatic Impairment, sponsored by Eisai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Plasma pharmacokinetic (PK) data were analyzed using a non-compartmental method of analysis.
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 |
What the finished NCT03440424 record still lists
NCT03440424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03440424's enrollment target sits among peer trials
24 33rd of 48 higher than 11 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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