Effect of Azimilide Dihydrochloride on Renal Function

NCT ID: NCT00318838

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-05-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days

2

125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days

Group Type: EXPERIMENTAL

Azimilide dihydrochloride

Intervention Type: DRUG

125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days

Interventions

Azimilide dihydrochloride

125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days

Intervention Type: DRUG

Placebo

Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Procter and Gamble Pharmaceuticals

Principal Investigators

Jose M Brum, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

Parexel CPRU, Harbor Hospital Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

2006022

Identifier Type: -

Identifier Source: org_study_id