Healthy Subjects Clinical Trial
Official 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
Verified date | July 2014 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Quintiles Phase I Services | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the effects of multiple doses of E5555 on single dose pharmacokinetics of metformin. | 15 days | No | |
Secondary | To assess the effects of multiple doses of E5555 on the glomerular filtration rate estimated using iohexol. | Days 7 and 14 | No | |
Secondary | 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 | No | |
Secondary | To assess the multiple dose pharmacokinetics of E5555 and its main 6 metabolites. | Days 12-18 | No | |
Secondary | 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 | Yes |
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