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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: E5555

• Registration Number: NCT01241669
• Lead Sponsor: Eisai Inc.

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 (OCT2) substrate. In addition, the study will also investigate the effects of E5555 on several renal function parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2011-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	E5555	-
Arm 2	E5555	-

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin.	15 days

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple doses of E5555 and a single dose of metformin either given alone or concomitantly	Day 1 - Day 18
To assess the effects of multiple doses of E5555 on the glomerular filtration rate estimated using iohexol.	Days 7 and 14
To assess the effects of multiple doses of E5555 on the effective renal plasma flow estimated using para-aminohippuric acid (PAH).	Days 7 and 14
To assess the multiple dose pharmacokinetics of E5555 and its main 6 metabolites.	Days 12-18

Trial Locations

Locations (1)

Quintiles Phase I Services; 🇺🇸 Overland Park, Kansas, United States