A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy

Study Overview
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Brief Summary
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The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Official Title
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BLI4700-301: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: BLI4700
* Drug: Polyethylene glycol 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. 18 to 85 years of age (inclusive) If female, and of child-bearing potential, is using an acceptable form of birth control Negative serum 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, gastrointestinal obstruction, gastroparesis, 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 taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain is not exclusionary. Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg). Subjects taking antibiotics within 7 days of colonoscopy. 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 with an abnormal and clinically significant physical examination or ECG finding at Visit 1. 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 component. Subjects using drugs of abuse, including abused prescription medications. Subjects who are withdrawing from alcohol or benzodiazepines. 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.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI4700 Bowel Preparation<br> | Drug: BLI4700<br>* Oral bowel preparation<br>|
| Active Comparator: FDA Approved Bowel Preparation<br> | Drug: Polyethylene glycol bowel preparation<br>* Oral bowel preparation<br>|

What is the study measuring?
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Primary Outcome Measures

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