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NCT01637636 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.
A Phase 1 study, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01637636 is a Phase 1 study that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 48 participants.
The verdict
NCT01637636, a Phase 1 study, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown product) in the blood when taken alone and in combination with either rifampin or ketoconazole. Cytochrome P450 3A4 is an important enzyme produced by the body to breakdown certain medications. In this study, the effect that this important enzyme has on tasimelteon is being studied by assessing the effect rifampin and ketoconazole have on tasimelteon and how they are broken down by your body. Rifampin is a known inducer of Cytochrome P450 3A4 enzyme meaning that it increases the activity of the enzyme. Ketoconazole is a known inhibitor of Cytochrome P450 3A4 enzyme meaning that it decreases the activity of the enzyme. In addition, the safety and tolerability of tasimelteon will also be assessed throughout the study.
Interventions
- DRUG Rifampin
- DRUG Ketoconazole
- DRUG tasimelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01637636
The ClinicalTrials.gov registry entry for NCT01637636 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 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 3 interventions - of which Rifampin is the first listed.
NCT01637636 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01637636 about?
NCT01637636 is a clinical study titled "Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.". The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown product) in the blood when taken alone and in combination with either rifampin or ketoconazole. Cytochrome P450 3A4 is an important enzyme produced by the body t...
What is the current status of trial NCT01637636?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2012-06. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01637636?
The interventions under investigation include: Rifampin (DRUG), Ketoconazole (DRUG), tasimelteon (DRUG).
Who is sponsoring clinical trial NCT01637636?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
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