A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.

Official Title
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A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: BLI4900
* Drug: PEG Control


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. 18 to 85 years of age (inclusive). 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 with ongoing severe, acute inflammatory bowel disease. Subjects who had previous significant gastrointestinal surgeries. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg). Subjects with severe renal insufficiency (GFR < 30 mL/min/1.73m2). Subjects with known severe hepatic insufficiency (Child Pugh C). Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4). Subjects undergoing insulin therapy for any indication. 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
Maximum Age: 85 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: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI4900<br>BLI4900 Bowel Preparation | Drug: BLI4900<br>* BLI4900 Bowel Preparation<br>|
| Active Comparator: PEG Control<br>Polyethylene glycol-based bowel preparation | Drug: PEG Control<br>* Polyethylene glycol-based bowel preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Subjects With Successful Bowel Preparation | % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent) | Day of colonoscopy |