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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: Completed Phase 1 study of Healthy Volunteers, sponsored by Vanda Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Composite of 24 hour pharmacokinetic parameters of midazolam will be compared between Day 1 and Day 18.
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 |
What the finished NCT01402076 record still lists
NCT01402076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT01402076's enrollment target sits among peer trials
24 204th of 283 higher than 66 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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