NCT01241669

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

November 15, 2010

Last Update Submit

July 10, 2014

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

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

    15 days

Secondary Outcomes (4)

  • 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

  • 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

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: E5555

Arm 2

EXPERIMENTAL
Drug: E5555

Interventions

E5555DRUG

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.

Arm 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles Phase I Services

Overland Park, Kansas, 661200, United States

Location

MeSH Terms

Interventions

E 5555

Study Officials

  • Dr. Bhaskar Rege

    Eisai Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

US(1)