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



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:10/19/2013
Start Date:August 2013
End Date:March 2014
Contact:Cheryl Chen
Email:cechen@neurocrine.com
Phone:858-617-7744

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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


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.


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.
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Minneapolis, Minnesota 55404
888-345-2567
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Lakewood, Colorado 80228
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