Trials / Completed
CompletedNCT03440424
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
An Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lemborexant | oral tablet |
Timeline
- Start date
- 2018-01-26
- Primary completion
- 2018-04-23
- Completion
- 2018-04-23
- First posted
- 2018-02-22
- Last updated
- 2020-03-20
- Results posted
- 2020-01-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03440424. Inclusion in this directory is not an endorsement.