HealthyPhase 4NCT00318201
The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers
A Phase 4 study testing Erythromycin and Diltiazem in people with Healthy, run by Indiana University at 1 site in United States.
Trial summary
We, the researchers at the Indiana University School of Medicine, are doing this study to better understand how the effects of certain medications are altered when taken simultaneously, or in combination with each other. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Erythromycin and Diltiazem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2007
- Phase
- Phase 4
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Approximately 45 healthy volunteers may be recruited to participate in the study, with a goal of 15 healthy volunteers (7 or 8 males) completing the entire four phases. All potential subjects:
- Must be a non-smoker
- Between 18 to 50 years of age
- Have a body mass index of 30 or less
- Must be willing to undergo a screening physical examination and proven to be free from metabolic, cardiac, pulmonary, renal or hepatic dysfunction as determined by the screening physical, medical history, 12-lead electrocardiography, and laboratory values which include: a CMP (complete metabolic profile), a CBC/diff/plt (complete blood count with differential and platelet count), serum pregnancy test (if applicable), and UA (urinalysis). Also, given the uncertain effects of these drugs on the fetus and the fact that hormonal contraceptives are prohibited, the female subjects should be on two other forms of birth control (e.g. condom, contraceptive foam).
Who cannot join
- Potential volunteers will be excluded:
- If they have allergies or are hypersensitive to any of the study medications:
- Midazolam (Versed) or related benzodiazepines drugs such as diazepam (Valium) or alprazolam (Xanax).
- Diltiazem (Cardizem, Dilacor) or related calcium channel blockers such as verapamil (Calan, Isoptin).
- Erythromycin (Erythrocin, E-mycin, Ery-tab) or related antibiotics such as clarithromycin (Biaxin) or have experienced abdominal pain when taking erythromycin or other related medications.
- If they are taking any prescription medication on a regular basis including contraceptives such as oral birth control pills, transdermal patches or injections (Depo-Provera).
Show all 20Show fewer
- If they are taking over-the-counter medications, any herbal or dietary supplement (including Benadryl, Sudafed, St. John's wort, herbal teas, vitamins and garlic supplements) that cannot be stopped for the study duration. Use of over-the-counter drugs for the treatment of minor, short-lived (2 to 3 days) symptoms may be allowable (such as Tylenol) but must first be approved by a study investigator.
- If they have donated blood within the past two months, or are anemic (have a hemoglobin level less than 12.5 mg/dl).
- If they weigh less than 52 kg, or have a BMI (Body Mass Index) greater than 32.
- If they have a screening or baseline EKG reading that is abnormal or could place them at higher risk as decided by the study doctors (baseline corrected QT interval in the EKG of 450 msec or greater or a baseline PR interval in the EKG of 210 msec or greater).
- If they have a history of bradycardia or consistently have a heart rate less than 55 beats per minutes.
- If they have any history of heart disease or have a family medical history of sudden death (heart stopping suddenly without warning).
- If they have a history of psychiatric problems that may be exacerbated by participation in this study, or if the subject can not state a good understanding of this study's risks and requirements.
- If they have a positive serum pregnancy test during the screening process or have a positive urine pregnancy test (UPT) which will be obtained just prior to each of the four study phases.
- If they are currently breastfeeding.
- If they have participated in any other study in which they have taken a research medication within the past three months.
- If they have a history of alcohol or drug abuse, or have used tobacco or marijuana within the past three months.
- If they are unwilling or unable to refrain from using drugs, alcohol, or any food listed on the exclusion list below during this study.
- If they are an employee or student under the supervision of any study investigator.
- If they are unwilling or unable to follow the study rules.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Medical Center / GCRC
Indianapolis, Indiana, 46202
About this study
We, the researchers at the Indiana University School of Medicine, are doing this study to better understand how the effects of certain medications are altered when taken simultaneously, or in combination with each other. We will also look at how each volunteer's genes (DNA) may affect the way these medications are metabolized.
Hypothesis:
We will test the hypothesis that the extent of drug-drug interaction caused by the combination of erythromycin and diltiazem is not predictable from the extent of interaction produced by each inhibitor alone. Specifically we will test the hypothesis that the combination of erythromycin and diltiazem will cause a greater decrease in midazolam intravenous and oral clearance than the sum of the decreases caused by each inhibitor alone.
Read the detailed description
Many drugs such as diltiazem are metabolized by CYP3A4, the cytochrome P450 enzyme responsible for the metabolism of erythromycin and when given together, the possibility exists that one drug inhibits the metabolism of the other leading to an increase in plasma concentration. The magnitude of this interaction is not known. It is therefore important to define this effect because diltiazem is a drug that is used commonly to treat hypertension, angina and atrial fibrillation and these patients may be given erythromycin for the treatment of intercurrent bacterial infections.
- Conditions
- Healthy
- Being tested
- Erythromycin, Diltiazem
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
DiltiazemDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Altered efficacy for drug to drug interaction of diltiazam with erythromycin Receives: Drug: Erythromycin; Drug: Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Aims: To quantify the extent of the drug-drug interaction between erythromycin and midazolam
Measured: 2 days
To quantify the extent of the drug-drug interaction between diltiazem and midazolam
Measured: 2 days
To quantify the extent of the drug-drug interaction between the combination of diltiazem and erythromycin, and midazolam
Measured: 2 days
Secondary outcomes (2)
Secondary Aims: To quantify the effects of erythromycin, diltiazem, and the combination of erythromycin and diltiazem on the electrocardiogram (EKG) PR interval
Measured: 2 days
To quantify the effects of erythromycin, diltiazem, and the combination of erythromycin and diltiazem on the heart-rate corrected QT interval of the EKG
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startApr 2006
- Study completionDec 2007
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.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Stephen D Hall, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318201
- Sponsor's protocol ID
- # 0412-09
- Other IDs
- R01GM067308/NIGMS, MO1RR000750/GCRC #1267, R01GM067308
- Status last verified
- Dec 2007
- First submitted
- 21 Apr 2006
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00318201
- Acronym / sponsor ID
- # 0412-09
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 26 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.
We, the researchers at the Indiana University School of Medicine, are doing this study to better understand how the effects of certain medications are altered when taken simultaneously, or in combination with each other. We will also look at how each volunteer's genes (DNA) may affect the way these medications are metabolized.
Hypothesis:
We will test the hypothesis that the extent of drug-drug interaction caused by the combination of erythromycin and diltiazem is not predictable from the extent of interaction produced by each inhibitor alone. Specifically we will test the hypothesis that the combination of erythromycin and diltiazem will cause a greater decrease in midazolam intravenous and oral clearance than the sum of the decreases caused by each inhibitor alone.
Detailed description
Many drugs such as diltiazem are metabolized by CYP3A4, the cytochrome P450 enzyme responsible for the metabolism of erythromycin and when given together, the possibility exists that one drug inhibits the metabolism of the other leading to an increase in plasma concentration. The magnitude of this interaction is not known. It is therefore important to define this effect because diltiazem is a drug that is used commonly to treat hypertension, angina and atrial fibrillation and these patients may be given erythromycin for the treatment of intercurrent bacterial infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Erythromycin, Drug: DiltiazemAltered efficacy for drug to drug interaction of diltiazam with erythromycin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Approximately 45 healthy volunteers may be recruited to participate in the study, with a goal of 15 healthy volunteers (7 or 8 males) completing the entire four phases. All potential subjects:
- Must be a non-smoker
- Between 18 to 50 years of age
- Have a body mass index of 30 or less
- Must be willing to undergo a screening physical examination and proven to be free from metabolic, cardiac, pulmonary, renal or hepatic dysfunction as determined by the screening physical, medical history, 12-lead electrocardiography, and laboratory values which include: a CMP (complete metabolic profile), a CBC/diff/plt (complete blood count with differential and platelet count), serum pregnancy test (if applicable), and UA (urinalysis). Also, given the uncertain effects of these drugs on the fetus and the fact that hormonal contraceptives are prohibited, the female subjects should be on two other forms of birth control (e.g. condom, contraceptive foam).
Key exclusion criteria (20 listed)
- If they have allergies or are hypersensitive to any of the study medications:
- If they are taking any prescription medication on a regular basis including contraceptives such as oral birth control pills, transdermal patches or injections (Depo-Provera).
- If they are taking over-the-counter medications, any herbal or dietary supplement (including Benadryl, Sudafed, St. John's wort, herbal teas, vitamins and garlic supplements) that cannot be stopped for the study duration. Use of over-the-counter drugs for the treatment of minor, short-lived (2 to 3 days) symptoms may be allowable (such as Tylenol) but must first be approved by a study investigator.
- If they have donated blood within the past two months, or are anemic (have a hemoglobin level less than 12.5 mg/dl).
- If they weigh less than 52 kg, or have a BMI (Body Mass Index) greater than 32.
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 |
|---|---|---|
| Erythromycin | Drug | 1 |
| Diltiazem | Drug | 1 |
Primary outcome
Primary Aims: To quantify the extent of the drug-drug interaction between erythromycin and midazolam
Time frame: 2 days
To quantify the extent of the drug-drug interaction between diltiazem and midazolam
Time frame: 2 days
To quantify the extent of the drug-drug interaction between the combination of diltiazem and erythromycin, and midazolam
Time frame: 2 days
2 secondary outcomes
Secondary Aims: To quantify the effects of erythromycin, diltiazem, and the combination of erythromycin and diltiazem on the electrocardiogram (EKG) PR interval
Time frame: 2 days
To quantify the effects of erythromycin, diltiazem, and the combination of erythromycin and diltiazem on the heart-rate corrected QT interval of the EKG
Time frame: 2 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 6 Apr 2012.
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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.
Stephen D Hall, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythromycin and Diltiazem in people with Healthy, run by Indiana University 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 6 Apr 2012. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Primary Aims: To quantify the extent of the drug-drug interaction between erythromycin and midazolam (time frame: 2 days). The study lists 3 primary outcomes in all. 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 6 Apr 2012.