Pharmacokinetics of AGO178 in Participants With Liver Impairment

NCT01531309 | Completed Phase 1

• 1 other identifier: CAGO178C2102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Impairment

Keywords

Liver impairment; Major Depression Disorder; Sublingual tablet

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of Participants with Adverse Events

  Baseline and Day 8

Study Arms (3)

Mild Hepatic Impaired Participants

EXPERIMENTAL

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

Drug: AGO178

Moderate Hepatic Impaired Participants

EXPERIMENTAL

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

Drug: AGO178

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

EXPERIMENTAL

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

Drug: AGO178

Interventions

AGO178 DRUG

AGO178 is administered as a sublingual tablet.

Also known as: Agomelatine

Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI); Mild Hepatic Impaired Participants; Moderate Hepatic Impaired Participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Servier: collaborator

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

agomelatine

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 10, 2012
• Study Start: February 8, 2011
• Primary Completion: September 2, 2011
• Study Completion: September 2, 2011
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (1)