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| Name | Class |
|---|---|
| Servier | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Hepatic Impaired Participants | Experimental | Mild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1. |
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| Moderate Hepatic Impaired Participants | Experimental | Moderate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1. |
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| Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI) | Experimental | Healthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGO178 | Drug | AGO178 is administered as a sublingual tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of AGO178 | Blood samples will be collected at various time points on day 1 and day 2 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
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| ID | Term |
|---|---|
| C084711 | agomelatine |
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