Pharmacokinetics of AGO178 in Participants With Liver Impairment

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531309
• Other study ID #: CAGO178C2102
• Status: Completed
• Phase: Phase 1
• Start date: February 8, 2011
• Est. completion date: September 2, 2011

Study information

• Verified date: May 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2, 2011
• Est. primary completion date: September 2, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• AGO178
AGO178 is administered as a sublingual tablet.

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Servier

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of AGO178	Blood samples will be collected at various time points on day 1 and day 2	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
Primary	Area Under the Plasma Curve (AUC) of AGO178	Blood samples will be collected at various time points on day 1 and day 2	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	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).	Baseline and Day 8