NCT01816191Unknown1 期
An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Single and multiple dose Pharmacokinetic parameters
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •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
- •Investigational agents
- •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/m
- •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.
研究组 & 干预措施
Diltiazem Hydrochloride
Experimental
Topical cream and oral pill
干预措施: Diltiazem Hydrochloride Cream and Oral Diltiazem (Drug)
结局指标
主要结局
Single and multiple dose Pharmacokinetic parameters
时间窗: up to 6 months after enrollment begins
Single- and multiple-dose PK parameters for topical DTZ and single-dose PK parameters for oral DTZ including AUC(0-t), AUC(0-∞), Cmax, tmax, t1/2 and CL/F. PK parameters for DTZ, and its two metabolites (N-desmethylditiazem and O-desacetyldiltiazem) will be presented in Data Listings and summarized by Day (Study Day 1, 7 and 14). Descriptive statistics will include n, mean, SD, %CV, geometric mean,median, minimum, and maximum.
次要结局
- Safety as determined by nature, severity and relationship of adverse events, clinical labs, physical exam findings, vital signs and Electrocardiogram(Up to 6 months after enrollment begins)
研究者
研究点 (1)
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