Pharmacokinetics of Agomelatine in Patients With Liver Impairment
Agomelatine (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 is to study the pharmacokinetics of agomelatine given as sublingual tablet in patients with liver impairment and to compare the results to those of healthy volunteers who receive the same treatment.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||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|
- Cmax of agomelatine (AGO178) [ Time Frame: Predose, 2 min , 5 min , 10 min, 20 min, 30 min, 45 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose ] [ Designated as safety issue: No ]Blood samples will be collected at various time points on day 1 and day 2
- Area under the plasma curve (AUC) of agomelatine (AGO178) [ Time Frame: Predose, 2 min , 5 min , 10 min, 20 min, 30 min, 45 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose ] [ Designated as safety issue: No ]Blood samples will be collected at various time points on day 1 and day 2
- Number of patients with adverse events [ Time Frame: Baseline and Day 8 ] [ Designated as safety issue: Yes ]Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments (clinical chemistry, hematology, urinalysis).
|Study Start Date:||February 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
AGO178 is administered as a sublingual tablet.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531309
|United States, Florida|
|Orlando Clinical Research Center|
|Orlando, Florida, United States, 32809|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|