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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014