A Phase 1 interventional study of E5555 and E5555 in Healthy Subjects, sponsored by Eisai Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-11.
Sponsored by Eisai Inc. · Phase 1, Interventional, and Treatment
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.
Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: E5555
Drug: E5555
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.
Drug: Oral E5555 100 mg/matching placebo, oral metformin 500 mg, iohexal 20 mL intravenous (IV), and para-aminohippuric acid (PAH) 7 mg/kg IV bolus.
To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin.
Time frame: 15 days
To assess the effects of multiple doses of E5555 on the glomerular filtration rate estimated using iohexol.
Time frame: 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).
Time frame: Days 7 and 14
To assess the multiple dose pharmacokinetics of E5555 and its main 6 metabolites.
Time frame: 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
Time frame: Day 1 - Day 18
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Eisai Inc.