CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 49 enrolled
Drug / intervention
MK-7655 +4 moredrug
Likely dose
MK-7655 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01275170
NCT01275170Phase 1Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Jan 12, 2011·Updated Jun 11, 2020

In Brief

A Phase 1 clinical trial evaluating MK-7655, Imipenem + Cilastatin, and 3 other interventions for Infectious Disease. Completed, enrolled 49 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfectious Disease
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2011
Enrollment StartJan 28, 2011
Primary CompletionMar 5, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.5 years ago

Interventions

MK-7655drug

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatindrug

250 mg IV over 30 minutes as a single dose

Caffeinedrug

Caffeine caplet, single 200 mg dose, orally

Midazolamdrug

Midazolam hcl syrup single 2.0 mg dose by mouth.

Omeprazoledrug

Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally