Pharmacokinetics of Agomelatine in Patients With Liver Impairment

This study has been completed.
Sponsor:
Collaborator:
Servier
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01531309
First received: February 3, 2012
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Hepatic Impairment
Drug: AGO178
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Enrollment: 32
Study Start Date: February 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGO178 Drug: AGO178
AGO178 is administered as a sublingual tablet.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531309

Locations
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Novartis Pharmaceuticals
Servier
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01531309     History of Changes
Other Study ID Numbers: CAGO178C2102
Study First Received: February 3, 2012
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Liver impairment
Major Depression Disorder
Sublingual tablet

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014