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NCT04029584 · ClinicalTrials.gov registry record · Phase 4
Drug-Drug Interaction Between Rifampin and Fluvastatin
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT04029584 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants.
The verdict
NCT04029584, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
The effect of organic anion transporting polypeptide 1B1 (OATP1B1) transporter inhibition at clinical doses of fluvastatin, a biopharmaceutics drug disposition classification system (BDDCS) class 1 drug, has not been studied to date. A single dose of IV rifampin can be used as model OATP1B1 inhibitor to evaluate the significance of OATP1B1 transporter effects on fluvastatin disposition. A preinduction regimen of oral rifampin followed by a single IV infusion of rifampin can be used to evaluate the combined effects of enzyme induction and OATP1B1 transporter inhibition on fluvastatin disposition. A two arm, randomized, open label, crossover clinical study in healthy, volunteers will be conducted to evaluate the effects of IV rifampin on fluvastatin disposition in both hepatically induced and uninduced subjects.
Interventions
- DRUG rifampin IV
- DRUG Rifadin 300Mg Capsule
- DRUG Fluvastatin 20 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-04-25 |
| Est. Completion | 2020-04-25 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04029584
The ClinicalTrials.gov registry entry for NCT04029584 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which rifampin IV is the first listed.
NCT04029584 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04029584 about?
NCT04029584 is a clinical study titled "Drug-Drug Interaction Between Rifampin and Fluvastatin". The effect of organic anion transporting polypeptide 1B1 (OATP1B1) transporter inhibition at clinical doses of fluvastatin, a biopharmaceutics drug disposition classification system (BDDCS) class 1 drug, has not been studied to date. A single dose of IV rifampin can be used as model OATP1B1 inhibito...
What is the current status of trial NCT04029584?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2019-04-25. Estimated completion is 2020-04-25.
What interventions are being tested in trial NCT04029584?
The interventions under investigation include: rifampin IV (DRUG), Rifadin 300Mg Capsule (DRUG), Fluvastatin 20 MG (DRUG).
Who is sponsoring clinical trial NCT04029584?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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