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NCT03311841 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03311841 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 32 participants.
The verdict
NCT03311841, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this open-label, 2-period, fixed-sequence study is to characterize the plasma pharmacokinetic profiles of midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin following a single oral dose administration of a microdose cocktail in healthy participants, in participants with mild, moderate, severe (not on dialysis) renal impairment, and in participants with end-stage renal disease (ESRD; on dialysis).
Interventions
- DRUG Rifampin
- DRUG Midazolam oral solution
- DRUG Dabigatran and pitavastatin oral solution
- DRUG Atorvastatin and rosuvastatin oral solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2018-08-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03311841
The ClinicalTrials.gov registry entry for NCT03311841 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Rifampin is the first listed.
NCT03311841 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03311841 about?
NCT03311841 is a clinical study titled "Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)". The purpose of this open-label, 2-period, fixed-sequence study is to characterize the plasma pharmacokinetic profiles of midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin following a single oral dose administration of a microdose cocktail in healthy participants, in participants wi...
What is the current status of trial NCT03311841?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-03-01. Estimated completion is 2018-08-02.
What interventions are being tested in trial NCT03311841?
The interventions under investigation include: Rifampin (DRUG), Midazolam oral solution (DRUG), Dabigatran and pitavastatin oral solution (DRUG), Atorvastatin and rosuvastatin oral solution (DRUG).
Who is sponsoring clinical trial NCT03311841?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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