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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-12-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

single dose of NBI-98854 50 mg capsule

Group Type EXPERIMENTAL

NBI-98854 50 mg capsule

Intervention Type DRUG

Mild Hepatic Impairment

single dose of NBI-98854 50 mg capsule

Group Type EXPERIMENTAL

NBI-98854 50 mg capsule

Intervention Type DRUG

Moderate Hepatic Impairment

single dose of NBI-98854 50 mg capsule

Group Type EXPERIMENTAL

NBI-98854 50 mg capsule

Intervention Type DRUG

Severe Hepatic Impairment

single dose of NBI-98854 50 mg capsule

Group Type EXPERIMENTAL

NBI-98854 50 mg capsule

Intervention Type DRUG

Interventions

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NBI-98854 50 mg capsule

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes