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

Completed · Phase 1

Conditions studied: CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]

In brief

The purpose of this study is to evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.

Key facts

Study ID

NCT02080780

Run by

Ventrus Biosciences, Inc

People needed

24

Starts

2013-09-01

Expected to finish

2013-10-01

Last updated by the study team

2014-04-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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;

Where it is running

• TKL Research — Paramus, New Jersey, United States

Full record on ClinicalTrials.gov

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