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

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

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

• NCT number: NCT01916993
• Study type: Interventional
• Source: Neurocrine Biosciences
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Completion date: December 2013