Pharmacokinetics of AGO178 in Participants With Liver Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-08

Study Completion Date

2011-09-02

Brief Summary

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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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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mild Hepatic Impaired Participants

Mild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1.

Group Type EXPERIMENTAL

AGO178

Intervention Type DRUG

AGO178 is administered as a sublingual tablet.

Moderate Hepatic Impaired Participants

Moderate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1.

Group Type EXPERIMENTAL

AGO178

Intervention Type DRUG

AGO178 is administered as a sublingual tablet.

Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI)

Healthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1.

Group Type EXPERIMENTAL

AGO178

Intervention Type DRUG

AGO178 is administered as a sublingual tablet.

Interventions

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AGO178

AGO178 is administered as a sublingual tablet.

Intervention Type DRUG

Other Intervention Names

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Agomelatine

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes