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NCT01271387 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment
A Phase 1 study of Hepatic Impairment, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01271387 is a Phase 1 study of Hepatic Impairment that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 29 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (19% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01271387, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to individuals who have normal liver function.
Conditions Studied
Interventions
- DRUG tasimelteon
Study Locations (1)
Florida
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01271387
The ClinicalTrials.gov registry entry for NCT01271387 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 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 (19% lower). The listed sponsor is Vanda Pharmaceuticals, which has 68 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 tasimelteon is the first listed.
NCT01271387 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01271387 about?
NCT01271387 is a clinical study titled "Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment". The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to individuals who have normal liver function.
What is the current status of trial NCT01271387?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2011-01. Estimated completion is 2011-08.
What conditions does trial NCT01271387 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT01271387?
The interventions under investigation include: tasimelteon (DRUG).
Who is sponsoring clinical trial NCT01271387?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01271387 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.