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

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.

Study Overview

• Status: Completed
• Conditions: Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
• Intervention / Treatment: Drug: NBI-98854 50 mg capsule

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • DaVita Clinical Research
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • DaVita Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Neurocrine Biosciences

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): January 16, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: NBI-98854-1303