Trials / Completed
CompletedNCT02452801
Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS 5461 in Subjects With Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate the effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 5461 | Single dose, given orally |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2015-05-25
- Last updated
- 2016-02-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02452801. Inclusion in this directory is not an endorsement.