MedTrace Logo

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

NCT01275170 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-06-11

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01275170 on ClinicalTrials.gov