NCT00318838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

April 25, 2006

Last Update Submit

January 31, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics in healthy subjects

    6 days

Study Arms (2)

1

PLACEBO COMPARATOR

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

Drug: Placebo

2

EXPERIMENTAL

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

Interventions

Azimilide dihydrochlorideDRUG

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

2
PlaceboDRUG

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

1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel CPRU, Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

azimilide

Study Officials

  • Jose M Brum, MD

    Procter and Gamble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

April 1, 2006

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)