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NCT01531309 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of AGO178 in Participants With Liver Impairment
A Phase 1 study of Hepatic Impairment, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT01531309 is a Phase 1 study of Hepatic Impairment that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 32 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01531309, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG AGO178
Study Locations (1)
Florida
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-02-08 |
| Est. Completion | 2011-09-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01531309
The ClinicalTrials.gov registry entry for NCT01531309 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which AGO178 is the first listed.
NCT01531309 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01531309 about?
NCT01531309 is a clinical study titled "Pharmacokinetics of AGO178 in Participants With Liver Impairment". 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 w...
What is the current status of trial NCT01531309?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-02-08. Estimated completion is 2011-09-02.
What conditions does trial NCT01531309 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT01531309?
The interventions under investigation include: AGO178 (DRUG).
Who is sponsoring clinical trial NCT01531309?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01531309 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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