A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Condition: Colonoscopy
Intervention: BLI4900; PEG Control
Intervention description: BLI4900 Bowel Preparation; Polyethylene glycol-based bowel preparation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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

Eligibility criteria:

        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.