Ignite Creation Date:
2025-12-25 @ 1:00 AM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT01916993
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2013-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
Sponsor:
Neurocrine Biosciences
Organization:
Study Overview
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
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: