NCT01275170

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

A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Subjects With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infectious Disease

Interventions

Type	Name	Description
DRUG	MK-7655	125 mg intravenous (IV) over 30 minutes as a single dose
DRUG	Imipenem + Cilastatin	250 mg IV over 30 minutes as a single dose
DRUG	Caffeine	Caffeine caplet, single 200 mg dose, orally
DRUG	Midazolam	Midazolam hcl syrup single 2.0 mg dose by mouth.
DRUG	Omeprazole	Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally

Timeline

• Start date: 2011-01-28
• Primary completion: 2012-03-05
• Completion: 2012-03-05
• First posted: 2011-01-12
• Last updated: 2020-06-11
• Results posted: 2019-07-19