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NCT01477619 · ClinicalTrials.gov registry record · Phase 1
Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects
A Phase 1 study, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01477619 is a Phase 1 study that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 60 participants.
The verdict
NCT01477619, a Phase 1 study, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study will provide an assessment of the effect, if any, of age and body size on the safety and tolerability profile and the pharmacokinetics of tasimelteon.
Interventions
- DRUG Tasimelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01477619
The ClinicalTrials.gov registry entry for NCT01477619 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanda Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tasimelteon is the first listed.
NCT01477619 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01477619 about?
NCT01477619 is a clinical study titled "Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects". The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study will provide an assessment of the effect, if any, of age and body size on the safety and tolerability profile and the ...
What is the current status of trial NCT01477619?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-11. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01477619?
The interventions under investigation include: Tasimelteon (DRUG).
Who is sponsoring clinical trial NCT01477619?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
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