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Completed

NCT Number: NCT01241669

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quintiles Phase I Services

Overland Park, Kansas, 661200, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E5555

Drug

Drug: Oral E5555 400 mg/matching placebo, oral metformin 500 mg, iohexal 20 mL intravenous (IV), and para-aminohippuric acid (PAH) 7 mg/kg IV.

Primary outcomes

  1. To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin.

    Time frame: 15 days

Secondary outcomes

  1. To assess the effects of multiple doses of E5555 on the glomerular filtration rate estimated using iohexol.

    Time frame: Days 7 and 14

  2. To assess the effects of multiple doses of E5555 on the effective renal plasma flow estimated using para-aminohippuric acid (PAH).

    Time frame: Days 7 and 14

  3. To assess the multiple dose pharmacokinetics of E5555 and its main 6 metabolites.

    Time frame: Days 12-18

  4. To assess the safety and tolerability of multiple doses of E5555 and a single dose of metformin either given alone or concomitantly

    Time frame: Day 1 - Day 18

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

A Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Multiple Doses of E5555 on the Pharmacokinetics of Metformin (a Substrate for OCT2 Transporter) and on Renal Function in Healthy Subjects

Important dates

Study start
2010
Primary completion
2011
First posted
Nov 16, 2010
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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