Healthy
Conditions
Brief 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.
Interventions
125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days
DRUGPlacebo
Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of multiple dosing of 125 mg azimilide on glomerular filtration rate and total creatinine clearance in healthy subjects | 6 days |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics in healthy subjects | 6 days |
Countries
United States
Outcome results
None listed