Effect of Azimilide Dihydrochloride on Renal Function

This study has been completed.
Sponsor:
Information provided by:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00318838
First received: April 25, 2006
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Azimilide dihydrochloride
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • To assess the effect of multiple dosing of 125 mg azimilide on glomerular filtration rate and total creatinine clearance in healthy subjects [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics in healthy subjects [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: April 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablet every 12 hours for 3 days followed by placebo 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
Experimental: 2
125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318838

Locations
United States, Maryland
Parexel CPRU, Harbor Hospital Center
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Jose M Brum, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Jose Brum, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00318838     History of Changes
Other Study ID Numbers: 2006022
Study First Received: April 25, 2006
Last Updated: March 22, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Azimilide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014