Pharmacokinetics of AGO178 in Participants With Liver Impairment

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: AGO178

• Registration Number: NCT01531309
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-08
• Primary Completion: 2011-09-02
• Study Completion: 2011-09-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Hepatic Impaired Participants	AGO178	Mild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1.
Moderate Hepatic Impaired Participants	AGO178	Moderate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1.
Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI)	AGO178	Healthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States