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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01916993

Enrollment

Registered

2013-08-06

Start date

2013-08-31

Completion date

2013-12-31

Last updated

2014-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DRUGNBI-98854 50 mg capsule

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026