CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]Phase 1NCT02080780
Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
A Phase 1 study testing Clarithromycin XL and 2% Diltiazem in people with CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction], run by Ventrus Biosciences, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]
- What is being tested?
- Clarithromycin XL and 2% Diltiazem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Were healthy subjects (as confirmed by medical history, laboratory work, and physical exam);
- Were between 18 and 60 years of age, inclusive;
- If of childbearing potential, were using an acceptable form of birth control (ie, nonhormonal intra-uterine device, diaphragm, condom, bilateral tubal ligation, abstinence, or were in a monogamous relationship with a partner who had a vasectomy);
- In the case of females of childbearing potential, had a negative serum pregnancy test (SPT) at Screening and a negative urine pregnancy test (UPT) at Study Day -1, (a woman was considered to be of childbearing potential unless she was postmenopausal for at least 12 months or was surgically sterile [hysterectomy, bilateral oophorectomy]);
- Had clinical lab tests (hematology, chemistry, and urinalysis), an electrocardiogram (ECG), and vital signs within normal limits, or assessed by the investigator as not of clinical significance; and
- Were able to read, understand, and provide signed informed consent.
Who cannot join
- On any drug treatment at the time of the study;
- Had donated plasma (500 mL) within 7 days prior to drug administration;
- Had donated or lost whole blood (excluding the volume of blood that was to be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration;
- Were using and were unwilling to stop any other concomitant topical preparations in or around the anus and perianal area from Day -1 through the end of the study;
- Had a hypersensitivity or allergy to the investigational compound/compound class used in this study, and bacterial fighting medications, including but not limited to clarithromycin XL , azithromycin, telithromycin, and erythromycin or to calcium channel blockers;
- Had a history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease, that, in the opinion of the investigator, could have interfered with the study conduct or observation;
Show all 44Show fewer
- Were unable to adhere to or understand the requirements of the protocol;
- Had a body mass index > 40 kg/m2;
- Had a screening ECG >470 QTCF for females and >450 QTCF for males;
- Were on active treatment with anti-viral therapies (eg, indinavir, nelfinavir, ritonavir) for human immunodeficiency virus (HIV);
- Had been treated with any of the following medications within 14 days prior to signing the ICF:
- CYP450 inhibitors and inducers;
- CYP3A4 substrates, inhibitors, and inducers;
- Benzodiazepines;
- β-adrenoceptor antagonists (beta-blockers);
- Calcium channel blockers;
- Digoxin;
- Investigational agents;
- Opioids.
- Had any of the following concomitant disease states:
- Sick sinus syndrome except in the presence of a functioning ventricular pacemaker;
- Second-or third-degree atrioventricular block except in the presence of a functioning ventricular pacemaker;
- Hypotension (< 90 mm Hg systolic);
- Acute myocardial infarction and pulmonary congestion documented by x-ray;
- History of clinically significant renal disease;
- History of clinically significant Alzheimer's or Parkinson's disease;
- History of clinically significant hepatic disease;
- Current infection treated with a macrolide antibiotic;
- Clinical evidence or history of fecal incontinence;
- Clinical evidence or history of anal fistula;
- Clinical evidence or history of anal abscess;
- History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis);
- History of any prior anal or rectal surgery including but not limited to: lateral sphincterotomy and anal stretch;
- Had a major organ transplant;
- Had a serious illness in the 4 weeks preceding the beginning of treatment (ie, that resulted in missed work or hospitalization);
- Had received treatment for any type of internal cancer within the 5 years prior to enrollment;
- Had, in the opinion of the investigator, clinically significant abnormal clinical laboratory results at the time of screening;
- Were females who were pregnant, were planning to become pregnant during the study, or were breastfeeding a child;
- Were currently using narcotics chronically;
- Were currently a smoker;
- Had used an investigational drug or had participated in an investigational study within 30 days prior to dosing;
- Had used prescription medication within 14 days prior to administration of study medication or over-the-counter (OTC) products (including natural food supplements vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption;
- Were an employee, family member, or student of the investigator or clinical site;
- Had any food allergy, intolerance, restriction, or special diet that, in the opinion of the investigator, could have contraindicated the subject's participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-label, Drug-drug Interaction Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
The purpose of this study is to evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
Read the detailed description
This study was designed to investigate the potential effect of clarithromycin XL at steady state (administered orally, once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg) on the PK of a single topical dose of diltiazem hydrochloride 2% cream applied to the perianal area (~2.5 cm [1 inch]; ~8.5 mg). This was a Phase 1 study with a single treatment arm. Efficacy was not assessed; therefore the study was of open-label design.
- Being tested
- Clarithromycin XL, 2% Diltiazem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin XLDrug
Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
2% DiltiazemDrug
2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)
| Study group | Role | What they receive |
|---|---|---|
| 2% Diltiazem & Clarithromycin XL | Experimental | 3 parts:
1. - Single Dose, Diltiazem (Day 1)
2. - Multiple Dose, Clarithromycin XL (Days 4-9)
3. - Single Dose, Diltiazem (Day 8) Receives: Drug: Clarithromycin XL; Drug: 2% Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of 2% Diltiazem
To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ventrus Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080780
- Sponsor's protocol ID
- VEN307-DDI-001
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2014
- Last updated
- 14 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label, Drug-drug Interaction Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02080780
- Acronym / sponsor ID
- VEN307-DDI-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ventrus Biosciences, IncIndustry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 14 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
Detailed description
This study was designed to investigate the potential effect of clarithromycin XL at steady state (administered orally, once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg) on the PK of a single topical dose of diltiazem hydrochloride 2% cream applied to the perianal area (~2.5 cm [1 inch]; ~8.5 mg). This was a Phase 1 study with a single treatment arm. Efficacy was not assessed; therefore the study was of open-label design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2% Diltiazem & Clarithromycin XL | Experimental | Drug: Clarithromycin XL, Drug: 2% Diltiazem3 parts: 1. - Single Dose, Diltiazem (Day 1) 2. - Multiple Dose, Clarithromycin XL (Days 4-9) 3. - Single Dose, Diltiazem (Day 8) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Were healthy subjects (as confirmed by medical history, laboratory work, and physical exam);
- Were between 18 and 60 years of age, inclusive;
- If of childbearing potential, were using an acceptable form of birth control (ie, nonhormonal intra-uterine device, diaphragm, condom, bilateral tubal ligation, abstinence, or were in a monogamous relationship with a partner who had a vasectomy);
- In the case of females of childbearing potential, had a negative serum pregnancy test (SPT) at Screening and a negative urine pregnancy test (UPT) at Study Day -1, (a woman was considered to be of childbearing potential unless she was postmenopausal for at least 12 months or was surgically sterile [hysterectomy, bilateral oophorectomy]);
- Had clinical lab tests (hematology, chemistry, and urinalysis), an electrocardiogram (ECG), and vital signs within normal limits, or assessed by the investigator as not of clinical significance; and
Key exclusion criteria (44 listed)
- On any drug treatment at the time of the study;
- Had donated plasma (500 mL) within 7 days prior to drug administration;
- Had donated or lost whole blood (excluding the volume of blood that was to be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration;
- Were using and were unwilling to stop any other concomitant topical preparations in or around the anus and perianal area from Day -1 through the end of the study;
- Had a hypersensitivity or allergy to the investigational compound/compound class used in this study, and bacterial fighting medications, including but not limited to clarithromycin XL , azithromycin, telithromycin, and erythromycin or to calcium channel blockers;
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 |
|---|---|---|
| Clarithromycin XLClarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg | Drug | 2% Diltiazem & Clarithromycin XL |
| 2% Diltiazem2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) | Drug | 2% Diltiazem & Clarithromycin XL |
Primary outcome
Peak Plasma Concentration (Cmax) of 2% Diltiazem
Time frame: 9 days
To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Clarithromycin XL and 2% Diltiazem in people with CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction], run by Ventrus Biosciences, Inc 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 6 inclusion and 44 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 14 Apr 2014. 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 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?
Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak Plasma Concentration (Cmax) of 2% Diltiazem (time frame: 9 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 14 Apr 2014.