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The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | single dose of NBI-98854 50 mg capsule |
|
| Mild Hepatic Impairment | Experimental | single dose of NBI-98854 50 mg capsule |
|
| Moderate Hepatic Impairment | Experimental | single dose of NBI-98854 50 mg capsule |
|
| Severe Hepatic Impairment | Experimental | single dose of NBI-98854 50 mg capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-98854 50 mg capsule | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 | 45 minutes prior to NBI-98854 dosing, and 15, 30, 45 minutes, and 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose | |
| Number of Participants with Adverse Events following dosing with NBI-98854 | Up to 36 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris O'Brien, MD | Neurocrine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Lakewood | Colorado | 80228 | United States | ||
| Orlando Clinical Research Center |
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| Orlando |
| Florida |
| 32809 |
| United States |
| Davita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| ID | Term |
|---|---|
| C000603978 | valbenazine |
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