An Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects

An Open Label Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects

This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be participating in this study. This study is composed of 2 parts:

Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an elected dose. A screening will be used to determine patients' suitability for inclusion in the trial. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose escalation. During this part, patients will undergo rectal manometry to determine anal pressure at baseline. Afterwards coated suppositories at various drug concentrations will be inserted and follow up manometries will be performed to determine response.

Patients that presented with an increase in rectal resting pressure without adverse events will enter the second part of the study. In this part, patients will be administered with a coated suppository, at a dose found at part 1 of the study to cause significant anal contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and 5 hours after insertion.

Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after administration.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Drug: coated suppository

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Zrifin, Israel
    • Gastroeneterology dept, Asaf harofe Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed written informed consent.
• Male or female subjects 18 to 55 years of age;

Exclusion Criteria:

• Known allergy to the active drug or excipients.
• Pregnancy or lactation.
• Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
• Type 1 diabetes mellitus;
• Insulin treated type 2 diabetes mellitus;
• Renal insufficiency.
• Liver insufficiency.
• Malignant disease within 5 years of screening;
• History of rectal surgery.
• History of HIV, hepatitis B, hepatitis C.
• Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
• Chronic use of medications with the exception of birth control pills.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: treatment	Drug: coated suppository; Dose escalating study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in resting anal pressure	The primary outcome is the change in resting anal pressure as measured 90 minutes after insertion of coated suppository and in comparison to baseline measurement taken before intervention.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug absorption	Blood samples for determining drug absorption be taken at times 0, 30, 60, 120, 180, 300 minutes after administration	1 day

Collaborators and Investigators

• Sponsor: RDD Pharma Ltd
• Investigators: Principal Investigator: Michael Shapiro, MD, Gastroenetrology dept, Asaf Harofe Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (ESTIMATE): December 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 21, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: RDD 107