A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

BLI4900-201

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

2017-11-09

2019-11-12

2019-11-12

Completed

Early phase I

121

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 121, 'type': 'ACTUAL'}}

2023-10-24