HealthyPhase 1NCT00318838
Effect of Azimilide Dihydrochloride on Renal Function
A Phase 1 study testing Azimilide dihydrochloride in people with Healthy, run by Forest Laboratories at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Azimilide dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to May 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel CPRU, Harbor Hospital Center
Baltimore, Maryland, 21225
About this study
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
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.
Read the 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
- Being tested
- Azimilide dihydrochloride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azimilide dihydrochlorideDrug
125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days
PlaceboDrug
Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days Receives: 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 Receives: Drug: Azimilide dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of multiple dosing of 125 mg azimilide on glomerular filtration rate and total creatinine clearance in healthy subjects
Measured: 6 days
Secondary outcomes (1)
To assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics in healthy subjects
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jose M Brum, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318838
- Sponsor's protocol ID
- 2006022
- Status last verified
- Jan 2017
- First submitted
- 25 Apr 2006
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00318838
- Acronym / sponsor ID
- 2006022
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days |
| 2 | Experimental | Drug: Azimilide dihydrochloride125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azimilide dihydrochloride125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days | Drug | 2 |
| PlaceboPlacebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days | Drug | 1 |
Primary outcome
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
1 secondary outcome
To assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics in healthy subjects
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose M Brum, MD study director
Procter and Gamble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azimilide dihydrochloride in people with Healthy, run by Forest Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.