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NCT01402076 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects
A Phase 1 study of Healthy Volunteers, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01402076 is a Phase 1 study of Healthy Volunteers that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 24 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01402076, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 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 midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone is given with tasimelteon.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Rosiglitazone
- DRUG Tasimelteon
Study Locations (1)
Missouri
- Bio-Kinetic Clinical Applications - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01402076
The ClinicalTrials.gov registry entry for NCT01402076 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, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The listed sponsor is Vanda Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Midazolam is the first listed.
NCT01402076 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT01402076 about?
NCT01402076 is a clinical study titled "A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects". The purpose of this research study is to understand whether there is any difference in the amount of midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone i...
What is the current status of trial NCT01402076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-08. Estimated completion is 2011-08.
What conditions does trial NCT01402076 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01402076?
The interventions under investigation include: Midazolam (DRUG), Rosiglitazone (DRUG), Tasimelteon (DRUG).
Who is sponsoring clinical trial NCT01402076?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01402076 being conducted?
This trial has 1 study location across Missouri. 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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