Effect of Azimilide Dihydrochloride on Renal Function

Forest Laboratories

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Azimilide dihydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00318838

2006022

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or hysterectomized or post-menopausal (last menstrual period > 1 year) female
Between 18 and 45 years of age, inclusive, at screening
In good general health based on medical history, physical examination and laboratory evaluation
Body mass index between 18 and 32 (kg/m2), inclusive
Willing and able to fulfill the requirements of the protocol and provide written consent

Exclusion criteria

History of diabetes, cardiovascular, hepatic, renal, or gastrointestinal disease
History of use of tobacco or nicotine-containing products within the past 3 months
Alcohol or illicit drug abuse or a reported habitual alcohol intake greater than 1.5 oz. (ethanol equivalent) per day (e.g., 24 ozs. of beer, 10 ozs. of wine, or 3 ozs. of hard liquor) within the past 2 years.
History of a clinically significant (in the opinion of the investigator) allergic reaction to any drug or multiple food/drug, contrast media agents, PAH, iodine or shell fish.
Clinically significant abnormality upon physical examination that, in the investigator's opinion, would interfere with the conduct of the study
Corrected QT-interval (QTc) > 440 msec (QT interval corrected for heart rate using Bazett's formula).
Clinically significant abnormality on screening 12-lead electrocardiogram (ECG); presence of discernable U wave that (in the investigator's opinion) would interfere with accurate measurement of QT at baseline and/or after treatment.
Personal or family history of long QT syndrome
Absolute neutrophil count < 1500/mm3
Potassium or magnesium value(s) outside the laboratory normal range
Any other laboratory value(s) outside the laboratory normal range considered clinically significant by the investigator (serum chemistry, hematology, coagulation, or urinalysis.
Serology positive for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) screen.
If female, positive urine or serum pregnancy test
Positive urine screen for drugs of abuse
Reported use of any prescription drug or herbal preparations within 14 days prior to dosing or any non-prescription drug or vitamin within 7 days prior to dosing.
Reported use of any known enzyme-inducer, enzyme-inhibitor, or other investigational drug within 30 days prior to dosing, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of dosing.
Blood donation of approximately 400 mL or more within 4 weeks or plasma donation of 200 mL or more within 2 weeks prior to dosing.
Acute illness within 2 weeks prior to dosing
History or presence, upon clinical evaluation, of any illness that might impact the safety of test product administration or evaluability of drug effect based on the investigator's discretion.
Has participated in another investigational drug study protocol within 30 days of admission.