NCT03311841

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

A Study to Assess the Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin Administered as Microdoses in Subjects With Varying Degrees of Renal Insufficiency in the Presence and Absence of Rifampin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Accepted

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).

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Midazolam oral solution	Midazolam hydrochloride 10 μg (1 mL of 10 μg/mL oral solution), administered orally as part of a microdose cocktail
DRUG	Dabigatran and pitavastatin oral solution	375/10 μg dabigatran etexilate and pitavastatin (1 mL of 375/10 μg/mL oral solution), administered orally as part of a microdose cocktail
DRUG	Atorvastatin and rosuvastatin oral solution	100/50 μg atorvastatin and rosuvastatin (2 mL of 50/25 μg/mL oral solution), administered orally as part of a microdose cocktail
DRUG	Rifampin	Rifampin 600 mg single dose (two 300 mg capsules) administered orally

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-08-02
• Completion: 2018-08-02
• First posted: 2017-10-17
• Last updated: 2020-01-09
• Results posted: 2020-01-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study