An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride

NCT ID: NCT01816191

Last Updated: 2013-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-09-30

Brief Summary

The study is a single-center, open-label, safety and pharmacokinetic study in12 adult subjects with Anal Fissures. Subjects will be screened to determine eligibility within 7 days of treatment. There will be three parts to the study and all subjects will participate in each part.

Conditions

Adult Subjects With Anal Fissures.

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diltiazem Hydrochloride

Topical cream and oral pill

Group Type: EXPERIMENTAL

Diltiazem Hydrochloride Cream and Oral Diltiazem

Intervention Type: DRUG

Interventions

Diltiazem Hydrochloride Cream and Oral Diltiazem

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with evidence of a circumscribed anal fissure, with induration at the edges.
• Any female of non-childbearing potential who:

a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post-menopausal (demonstration of total cessation of menses for ≥ 1 year from the date of the screening visit).

• Any female of child bearing potential must agree to use at least one form of contraception(may be a barrier method), during the full duration of the study.
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
• Capable of and freely willing to provide written informed consent prior to participating in the study.

Exclusion Criteria

• Unwilling to have visual or medical examination of the Anal Fissure.
• More than 1 Anal Fissure.
• Subjects with Anal Fissure associated with or caused by other conditions, including but not limited to: drug-induced, trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or malignancy.
• Unwilling to stop all other concomitant topical preparations applied in and around the anus from Day -1 through end of the study.
• Use of sitz bath from signing of ICF (Informed Consent Form) to end of study.
• Use of anesthetics from signing the ICF to end of study.
• Subfissure injection of botulinum toxin in the 3 months prior to signing the ICF.
• Known sensitivity to investigational product(s) or calcium channel blockers.
• Active treatment with anti-viral therapies for HIV (e.g. indinavir, nelfinivir,ritonavir).

10. Treatment with any prohibited medications within 14 days prior to signing the ICF:

• Cytochrome P450 (CYP450) inhibitors and inducers
• Cytochrome P3A4 (CYP3A4) substrates, inhibitors, and inducers
• Benzodiazepines
• β-adrenoceptor antagonists (Beta-Blockers)
• Calcium channel blockers
• Digoxin
• Investigational agents
• Opioids
• Following concomitant disease state:

• 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 (less than 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 (e.g. Crohn's disease, Ulcerative Colitis).
• History of any prior anal or rectal surgery including but not limited to: lateral sphincterotomy and anal stretch.
• History of radiation therapy to the pelvis.
• Fixed anal stenosis/fibrosis.
• Major organ transplant.
• Any clinically significant laboratory abnormalities during screening.
• BMI > 40 kg/m2.
• Malignancy within 5 years prior to randomization (with the exception of treated basal cell/squamous cell carcinoma of the skin).
• Any disease or prior/planned surgery that may interfere with the subject successfully completing the study.
• Currently using narcotic(s) chronically.
• Breast-feeding females.
• Employees, family members, or students of the investigator or clinical site.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ventrus Biosciences, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wake Research Associates

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

VEN307-PK-001

Identifier Type: -

Identifier Source: org_study_id