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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: E5555

Study type: Interventional

Funder types: Industry

Identifiers

NCT01241669

E5555-A001-023

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: E5555

Drug: E5555

Arm 2

Experimental group

Treatment:

Drug: E5555

Drug: E5555