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

NCT01816191 | Unknown Phase 1

• 1 other identifier: VEN307-PK-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Outcome Measures

Primary Outcomes (1)

• Single and multiple dose Pharmacokinetic parameters

  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.

  up to 6 months after enrollment begins

Secondary Outcomes (1)

• 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

Study Arms (1)

Diltiazem Hydrochloride

EXPERIMENTAL

Topical cream and oral pill

Drug: Diltiazem Hydrochloride Cream and Oral Diltiazem

Interventions

Diltiazem Hydrochloride Cream and Oral Diltiazem DRUG

Diltiazem Hydrochloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ventrus Biosciences, Inc: lead

Study Sites (1)

Wake Research Associates

Raleigh, North Carolina, United States

Location

MeSH Terms

Interventions

Diltiazem

Intervention Hierarchy (Ancestors)

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

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 13, 2013
• First Posted: March 22, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 21, 2013

Record last verified: 2013-07

Locations

US (1)