Pharmacokinetics of AGO178 in Participants With Liver Impairment

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531309

Enrollment

Registered

2012-02-10

Start date

2011-02-08

Completion date

2011-09-02

Last updated

2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Liver impairment, Major Depression Disorder, Sublingual tablet

Brief summary

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.

Interventions

DRUGAGO178

AGO178 is administered as a sublingual tablet.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax) of AGO178	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
Area Under the Plasma Curve (AUC) of AGO178	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

Measure	Time frame	Description
Number of Participants with Adverse Events	Baseline and Day 8	Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments (clinical chemistry, hematology, urinalysis).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026