Hepatic ImpairmentPhase 1NCT01531309
Pharmacokinetics of AGO178 in Participants With Liver Impairment
A Phase 1 study testing AGO178 in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- AGO178
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2011to 2 Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
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
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
- Being tested
- AGO178
- Keywords
- Liver impairment, Major Depression Disorder, Sublingual tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGO178Drug
Also called Agomelatine
AGO178 is administered as a sublingual tablet.
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Impaired Participants | Experimental | Mild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1. Receives: Drug: AGO178 |
| Moderate Hepatic Impaired Participants | Experimental | Moderate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1. Receives: 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. Receives: Drug: AGO178 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of AGO178
Blood samples will be collected at various time points on day 1 and day 2
Measured: 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
Measured: 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
Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments (clinical chemistry, hematology, urinalysis).
Measured: Baseline and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study start8 Feb 2011
- Primary completion2 Sep 2011
- Study completion2 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Servier
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531309
- Sponsor's protocol ID
- CAGO178C2102
- Status last verified
- May 2021
- First submitted
- 3 Feb 2012
- Last updated
- 11 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01531309
- Acronym / sponsor ID
- CAGO178C2102
- Conditions
- Hepatic Impairment
- Keywords
- Liver impairment, Major Depression Disorder, Sublingual tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Servier
- Study start
- 8 Feb 2011 (actual)
- Primary completion
- 2 Sep 2011 (actual)
- Study completion
- 2 Sep 2011 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Impaired Participants | Experimental | Drug: AGO178Mild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1. |
| Moderate Hepatic Impaired Participants | Experimental | Drug: AGO178Moderate 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) | Experimental | Drug: AGO178Healthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGO178Also: AgomelatineAGO178 is administered as a sublingual tablet. | Drug | Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI), Mild Hepatic Impaired Participants, Moderate Hepatic Impaired Participants |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of AGO178
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
Blood samples will be collected at various time points on day 1 and day 2
Area Under the Plasma Curve (AUC) of AGO178
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
Blood samples will be collected at various time points on day 1 and day 2
1 secondary outcome
Number of Participants with Adverse Events
Time frame: Baseline and Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGO178 in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of AGO178 (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.