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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: Completed Phase 1 study of Hepatic Impairment, sponsored by Vanda Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess plasma concentrations and pharmacokinetics of tasimelteon in subjects with mild or moderate hepatic impairment compared to healthy subjects with normal hepatic 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 |
What the finished NCT01271387 record still lists
NCT01271387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (19% lower).
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 a single indexed study location in 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
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01271387's enrollment target sits among peer trials
29 26th of 48 higher than 23 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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