A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing Colonoscopy

Study Overview
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Brief Summary
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To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a bowel preparation prior to colonoscopy in adult patients.

Conditions
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Bowel Preparation for Colonoscopy

Intervention / Treatment
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* Drug: BLI4600 bowel preparation
* Drug: PEG based bowel preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication At least 18 years of age If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse). Negative urine pregnancy test at screening, if applicable In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Exclusion Criteria: Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass, stomach stapling). Subjects with uncontrolled pre-existing electrolyte abnormalities, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors. Subjects with a prior history of renal, liver or cardiac insufficiency. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. Subjects undergoing colonoscopy for foreign body removal and/or decompression. Subjects who are pregnant or lactating, or intending to become pregnant during the study. Subjects of childbearing potential who refuse a pregnancy test. Subjects allergic to any preparation components. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days. Subjects who withdraw consent before completion of Visit 1 procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI4600 Regimen 1<br>Oral bowel preparation for colonoscopy | Drug: BLI4600 bowel preparation<br>* Oral bowel preparation for colonoscopy<br>|
| Experimental: BLI4600 Regimen 2<br>Oral bowel preparation for colonoscopy | Drug: BLI4600 bowel preparation<br>* Oral bowel preparation for colonoscopy<br>|
| Active Comparator: PEG based below preparation<br>Oral bowel preparation for colonoscopy | Drug: PEG based bowel preparation<br>* Oral bowel preparation for colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of subjects with successful preparation on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent) | % of subjects with successful preparation by colonoscopist on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent) | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ottawa Bowel Preparation Scale Score |  | 1 Day |