Trials / Completed
CompletedNCT03443063
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (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 severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lemborexant | oral tablet |
Timeline
- Start date
- 2018-02-07
- Primary completion
- 2018-08-24
- Completion
- 2018-08-24
- First posted
- 2018-02-22
- Last updated
- 2020-03-12
- Results posted
- 2020-01-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03443063. Inclusion in this directory is not an endorsement.