NCT03311841View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

August 2, 2018

Study Completion Date

August 2, 2018

Conditions
Renal Insufficiency
Interventions
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

Trial Locations (2)

32809

Orlando Clinical Research Center ( Site 0002), Orlando

33014

Clinical Pharmacology of Miami ( Site 0001), Hialeah

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03311841 - Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386) | Biotech Hunter | Biotech Hunter