Status:
COMPLETED
Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity
Lead Sponsor:
Eisai Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 (OCT...
Eligibility Criteria
Inclusion
- \- Healthy male or female subjects aged greater than or equal to 18 years to 55 years
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01241669
Start Date
October 1 2010
Last Update
July 11 2014
Active Locations (1)
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1
Quintiles Phase I Services
Overland Park, Kansas, United States, 661200