NCT01531309

Pharmacokinetics of AGO178 in Participants With Liver Impairment

An Open-Label, Parallel-Group Study to Compare the Pharmacokinetics, Safety and Tolerability of a Single Sublingual 1 mg Dose of AGO178 in Subjects With Mild and Moderate Hepatic Impairment With That in Matched Healthy Control Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

AGO178 was developed for the treatment of depression. A new formulation is being tested in the present study: a tablet to be placed and dissolved under the tongue (sublingual tablet). The goal of this trial was to study the pharmacokinetics of agomelatine given as sublingual tablet in participants with liver impairment and to compare the results to those of healthy volunteers who receive the same treatment.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	AGO178	AGO178 is administered as a sublingual tablet.

Timeline

• Start date: 2011-02-08
• Primary completion: 2011-09-02
• Completion: 2011-09-02
• First posted: 2012-02-10
• Last updated: 2021-05-11

Locations

1 site across 1 country: United States