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

Phase 1

Completed

• Conditions: Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
• Interventions: Drug: NBI-98854 50 mg capsule

• Registration Number: NCT01916993
• Lead Sponsor: Neurocrine Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	NBI-98854 50 mg capsule	single dose of NBI-98854 50 mg capsule
Mild Hepatic Impairment	NBI-98854 50 mg capsule	single dose of NBI-98854 50 mg capsule
Moderate Hepatic Impairment	NBI-98854 50 mg capsule	single dose of NBI-98854 50 mg capsule
Severe Hepatic Impairment	NBI-98854 50 mg capsule	single dose of NBI-98854 50 mg capsule

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

DaVita Clinical Research; 🇺🇸 Lakewood, Colorado, United States

Davita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States