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Pharmacokinetics of Agomelatine in Patients With Liver Impairment

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ClinicalTrials.gov Identifier: NCT01531309
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
Servier
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: AGO178 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : February 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: AGO178 Drug: AGO178
AGO178 is administered as a sublingual tablet.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Blood samples will be collected at various time points on day 1 and day 2

  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 ]
    Blood samples will be collected at various time points on day 1 and day 2


Secondary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Baseline and Day 8 ]
    Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments (clinical chemistry, hematology, urinalysis).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with liver disease confirmed within 3 months of screening
  • If liver impairment is caused by alcohol use, patients must have abstained from alcohol use within 3 months of study start
  • Patients must satisfy criteria for Child- Pugh Class A or B

Exclusion Criteria:

  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study
  • Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing
  • Significant illness within the two weeks prior to the dosing
  • Patients with Child-Pugh alterations due to a non-liver disease (e.g. cancer or treatment related weight loss).

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531309


Locations
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United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Novartis Pharmaceuticals
Servier
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01531309    
Other Study ID Numbers: CAGO178C2102
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: March 2013
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Liver impairment
Major Depression Disorder
Sublingual tablet
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
S 20098
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs