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NCT Number: NCT01531309

Pharmacokinetics of AGO178 in Participants With Liver Impairment

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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Key information

Conditions

Hepatic Impairment

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with liver disease confirmed within 3 months of screening.
  • If liver impairment is caused by alcohol use, participants must have abstained from alcohol use within 3 months of study start.
  • Participants 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 millilitres (mL) or more of blood within eight (8) weeks prior to initial dosing.
  • Significant illness within the two weeks prior to the dosing.
  • Participants 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.

Treatment and study plan

AGO178

Drug

AGO178 is administered as a sublingual tablet.

Other names: Agomelatine

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of AGO178

    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

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

  2. Area Under the Plasma Curve (AUC) of 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 outcomes

  1. Number of Participants 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).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Servier

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2012
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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