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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
AGO178 is administered as a sublingual tablet.
Orlando Clinical Research Center
Orlando, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of AGO178
Blood samples will be collected at various time points on day 1 and day 2
Time frame: Predose, 2 minute (min) , 5 min , 10 min, 20 min, 30 min, 45 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose
Area Under the Plasma Curve (AUC) of AGO178
Blood samples will be collected at various time points on day 1 and day 2
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
Number of Participants with Adverse Events
Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments (clinical chemistry, hematology, urinalysis).
Time frame: Baseline and Day 8
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