NCT00318838

Effect of Azimilide Dihydrochloride on Renal Function

A Double-blind, Randomized, Parallel-group, Placebo-controlled, Multiple-dose Study to Assess the Effect of 125 mg/Day Orally Administered Azimilide Dihydrochloride on Renal Function and Hemodynamics in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will assess the effect of multiple dosing of 125 mg azimilide on glomerular filtration rate (GFR) and total creatinine clearance (GFR + active secretion) in healthy subjects. Also, it will assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics (RPF) in healthy subjects.

Detailed description

This is a double-blind, parallel-group, placebo-controlled, multiple-dose, single-site study in healthy male and female volunteers. Oral azimilide 125 mg or placebo will be administered every 12 hours for 3 days, followed by 125 mg every 24 hours for 3 days. The study will include a total of 21 healthy subjects (14 active and 7 placebo), all of whom will be confined at the study center for 9 nights.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Azimilide dihydrochloride	125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days
DRUG	Placebo	Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2006-04-27
• Last updated: 2017-02-01

Locations

1 site across 1 country: United States