Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)

• Status: Completed
• Trial end date: 2018-08-02

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).

• Phase: Phase 1

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atorvastatin; Atorvastatin Calcium; Dabigatran; Midazolam; Pharmaceutical Solutions; Pitavastatin; Rifampin; Rosuvastatin Calcium