Clinical trial NCT01265485: An Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
Official title: An Open Label Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fecal Incontinence
Lead sponsor: RDD Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2010-12-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in resting anal pressure
timeFrame: 1 day
Secondary outcomes:
measure: Drug absorption
timeFrame: 1 day
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Gastroeneterology dept, Asaf harofe Medical center
Study officials:
affiliation: Gastroenetrology dept, Asaf Harofe Medical Center
name: Michael Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: