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

NCT02080780 | Completed Phase 1 Results

• 1 other identifier: VEN307-DDI-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax) of 2% Diltiazem

  To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.

  9 days

Study Arms (1)

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)

Drug: Clarithromycin XL; Drug: 2% Diltiazem

Interventions

Clarithromycin XL DRUG

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% Diltiazem & Clarithromycin XL

2% Diltiazem DRUG

2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg)

2% Diltiazem & Clarithromycin XL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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);

Sponsors & Collaborators

• Ventrus Biosciences, Inc: lead
• TKL Research, Inc.: collaborator

Study Sites (1)

TKL Research

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Interventions

Diltiazem

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ventrus
• Organization: Ventrus Biosciences

VEN307@ventrusbio.com

646-706-5208

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: September 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 14, 2014
• Results First Posted: April 14, 2014

Record last verified: 2014-03

Locations

US (1)