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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Ventrus Biosciences, Inc

Current Primary Outcome: Single and multiple dose Pharmacokinetic parameters [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Adverse events, physical examination findings, vital sign measurements, ECG results, and clinical laboratory data will be reviewed and summarized to evaluate the safety profile of topical DTZ cream and oral DTZ. Safety data will be summarized by study time point, and by change from Baseline using descriptive statistics as appropriate. Data listings will also be provided.


Original Secondary Outcome: Same as current

Information By: Ventrus Biosciences, Inc

Dates:
Date Received: March 13, 2013
Date Started: February 2013
Date Completion: September 2013
Last Updated: August 19, 2013
Last Verified: July 2013