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NCT01540500 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine
A Phase 1 study, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01540500 is a Phase 1 study that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 24 participants.
The verdict
NCT01540500, a Phase 1 study, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study.
Interventions
- DRUG Fluvoxamine
- DRUG Tasimelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01540500
The ClinicalTrials.gov registry entry for NCT01540500 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 2 interventions - of which Fluvoxamine is the first listed.
NCT01540500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01540500 about?
NCT01540500 is a clinical study titled "Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine". The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study.
What is the current status of trial NCT01540500?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01540500?
The interventions under investigation include: Fluvoxamine (DRUG), Tasimelteon (DRUG).
Who is sponsoring clinical trial NCT01540500?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
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