drugset / Trial / NCT03311841
Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)
Non-randomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2018-03-01
- Primary completion
- 2018-08-02
- Completion
- 2018-08-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 100 ug | Oral |
| Subject | Dabigatran etexilate | Unknown | 375 ug | Oral |
| Subject | Midazolam | Small molecule | 10 ug | Oral |
| Subject | Pitavastatin | Small molecule | 10 ug | Oral |
| Subject | Rifampin | Small molecule | 600 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 50 ug | Oral |