Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild, Moderate, or Severe Hepatic Insufficiency

Conditions
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Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects

Intervention / Treatment
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* Drug: NBI-98854 50 mg capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 to 75 years of age. Healthy volunteers must be in good general health. Subjects with hepatic impairment must be judged to be in stable condition. Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeeding. Have a body mass index (BMI) of 18 to 40 kg/m2 (both inclusive). Exclusion Criteria: Report more than two alcoholic beverages daily or more than 14 alcoholic beverages weekly withing 7 days of study start. Have a known history of neuroleptic malignant syndrome. Have a positive human immunodeficiency virus (HIV) antibody result at screening or have a history of positive result. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study. Have an allergy, hypersensitivity, or intolerance to tetrabenazine. Had a blood loss greater than or equal to 500 mL or donated blood within 56 days of study start. Have had previous exposure with NBI-98854.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br>single dose of NBI-98854 50 mg capsule | Drug: NBI-98854 50 mg capsule<br> <br> |
| Experimental: Mild Hepatic Impairment<br>single dose of NBI-98854 50 mg capsule | Drug: NBI-98854 50 mg capsule<br> <br> |
| Experimental: Moderate Hepatic Impairment<br>single dose of NBI-98854 50 mg capsule | Drug: NBI-98854 50 mg capsule<br> <br> |
| Experimental: Severe Hepatic Impairment<br>single dose of NBI-98854 50 mg capsule | Drug: NBI-98854 50 mg capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |