Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

This is a drug-drug interaction study to evaluate the effects of steady-state exposure of E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of E5555 on several renal function parameters.

Key facts

Study ID

NCT01241669

Run by

Eisai Inc.

People needed

104

Starts

2010-10-01

Last updated by the study team

2014-07-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female subjects aged greater than or equal to 18 years to 55 years

You may not qualify if…

• History of any medical condition which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis, etc.
• Creatinine clearance < 90 mL/min as estimated using Cockcroft-Gault formula at screening or baseline
• History of any renal disorders, proteinuria, hepato-biliary disease.

Where it is running

• Quintiles Phase I Services — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.