drugset / Trial / NCT01275170

A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)

NCT01275170

Phase 1 Completed 49 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a 2-part study of the pharmacokinetics (PK) of MK-7655. In Part I, the PK of a single 125 mg dose of MK-7655 given in combination with 250 mg of PRIMAXIN® (imipenem + cilastatin) will be determined in participants with impaired renal function and matched control participants. In Part II, the potential for renal insufficiency to affect non-renal clearance mechanisms will be investigated.

Timeline

Start
2011-01-28
Primary completion
2012-03-05
Completion
2012-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 200 mg Oral
Subject Cilastatin Small molecule Intravenous
Subject IMIPENEM ANHYDROUS Small molecule Intravenous
Subject Midazolam Small molecule 2 mg Oral
Subject Omeprazole Other / unclassified 40 mg Oral
Subject Relebactam Small molecule 125 mg Intravenous

Indications