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Trial record 2 of 393 for:    CLARITHROMYCIN

Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02080780
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Ventrus Biosciences, Inc

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 6, 2014
Results First Submitted Date  ICMJE March 7, 2014
Results First Posted Date  ICMJE April 14, 2014
Last Update Posted Date April 14, 2014
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02080780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
Official Title  ICMJE Phase 1, Open-label, Drug-drug Interaction Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]
Intervention  ICMJE
  • Drug: Clarithromycin XL
    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
  • Drug: 2% Diltiazem
    2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)
Study Arms  ICMJE Experimental: 2% Diltiazem & Clarithromycin XL

3 parts:

  1. - Single Dose, Diltiazem (Day 1)
  2. - Multiple Dose, Clarithromycin XL (Days 4-9)
  3. - Single Dose, Diltiazem (Day 8)
Interventions:
  • Drug: Clarithromycin XL
  • Drug: 2% Diltiazem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2014)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Were healthy subjects (as confirmed by medical history, laboratory work, and physical exam);
  2. Were between 18 and 60 years of age, inclusive;
  3. 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);
  4. 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]);
  5. 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
  6. Were able to read, understand, and provide signed informed consent.

Exclusion Criteria:

  1. On any drug treatment at the time of the study;
  2. Had donated plasma (500 mL) within 7 days prior to drug administration;
  3. 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;
  4. 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;
  5. 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;
  6. 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;
  7. Were unable to adhere to or understand the requirements of the protocol;
  8. Had a body mass index > 40 kg/m2;
  9. Had a screening ECG >470 QTCF for females and >450 QTCF for males;
  10. Were on active treatment with anti-viral therapies (eg, indinavir, nelfinavir, ritonavir) for human immunodeficiency virus (HIV);
  11. 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.
  12. 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;
  13. Had a major organ transplant;
  14. Had a serious illness in the 4 weeks preceding the beginning of treatment (ie, that resulted in missed work or hospitalization);
  15. Had received treatment for any type of internal cancer within the 5 years prior to enrollment;
  16. Had, in the opinion of the investigator, clinically significant abnormal clinical laboratory results at the time of screening;
  17. Were females who were pregnant, were planning to become pregnant during the study, or were breastfeeding a child;
  18. Were currently using narcotics chronically;
  19. Were currently a smoker;
  20. Had used an investigational drug or had participated in an investigational study within 30 days prior to dosing;
  21. 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;
  22. Were an employee, family member, or student of the investigator or clinical site;
  23. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02080780
Other Study ID Numbers  ICMJE VEN307-DDI-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ventrus Biosciences, Inc
Study Sponsor  ICMJE Ventrus Biosciences, Inc
Collaborators  ICMJE TKL Research, Inc.
Investigators  ICMJE Not Provided
PRS Account Ventrus Biosciences, Inc
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP