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Pharmacokinetics of AGO178 in Participants With Liver Impairment

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AGO178

About this trial

This is an interventional other trial for Hepatic Impairment focused on measuring Liver impairment, Major Depression Disorder, Sublingual tablet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Mild Hepatic Impaired Participants

Moderate Hepatic Impaired Participants

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of AGO178

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

Area Under the Plasma Curve (AUC) of AGO178

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

Secondary Outcome Measures

Number of Participants with Adverse Events

Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments (clinical chemistry, hematology, urinalysis).

Full Information

NCT ID

NCT01531309

First Posted

February 3, 2012

Last Updated

May 6, 2021

Sponsor

Novartis Pharmaceuticals

Collaborators

Servier

1. Study Identification

Unique Protocol Identification Number

NCT01531309

Brief Title

Pharmacokinetics of AGO178 in Participants With Liver Impairment

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 Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

February 8, 2011 (Actual)

Primary Completion Date

September 2, 2011 (Actual)

Study Completion Date

September 2, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

Collaborators

Servier

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

Keywords

Liver impairment, Major Depression Disorder, Sublingual tablet

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild Hepatic Impaired Participants

Arm Type

Experimental

Arm Description

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

Arm Title

Moderate Hepatic Impaired Participants

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AGO178

Other Intervention Name(s)

Agomelatine

Intervention Description

AGO178 is administered as a sublingual tablet.

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax) of AGO178

Description

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

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

Title

Area Under the Plasma Curve (AUC) of AGO178

Description

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

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

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Description

Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments (clinical chemistry, hematology, urinalysis).

Time Frame

Baseline and Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

12. IPD Sharing Statement

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Pharmacokinetics of AGO178 in Participants With Liver Impairment

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