Trials / Completed
CompletedNCT02859207
A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
An Open-Label Parallel-Group Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the study is to evaluate the effects of hepatic impairment on the pharmacokinetics (PK) of E2609 after a single dose administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E2609 | Participants will receive a single 50-mg dose (1× 50-mg E2609 tablet). |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2016-12-06
- Completion
- 2017-01-25
- First posted
- 2016-08-08
- Last updated
- 2017-06-08
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02859207. Inclusion in this directory is not an endorsement.