NCT00858156

BG9928 in Subjects With Hepatic Impairment

An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Oral BG9928 in Subjects With Mild and Moderate Hepatic Impairment and in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic function.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	BG9928	Oral 75 mg single dose

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-03-09
• Last updated: 2010-01-27

Locations

2 sites across 1 country: United States