An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
This trial is active, not recruiting.
|Condition||adult subjects with anal fissures.|
|Treatment||diltiazem hydrochloride cream and oral diltiazem|
|Sponsor||Ventrus Biosciences, Inc|
|Start date||February 2013|
|End date||July 2013|
|Trial size||12 participants|
|Trial identifier||NCT01816191, VEN307-PK-001|
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.
|Endpoint classification||pharmacokinetics study|
|Intervention model||single group assignment|
Topical cream and oral pill
Single and multiple dose Pharmacokinetic parameters
time frame: up to 6 months after enrollment begins
Safety as determined by nature, severity and relationship of adverse events, clinical labs, physical exam findings, vital signs and Electrocardiogram
time frame: Up to 6 months after enrollment begins
Male or female participants from 18 years up to 75 years old.
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.
|Official title||An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride|
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