Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

Key Inclusion Criteria:

• Male or female between the ages of 12 to 17
• Weight more than 40kg
• Undergoing colonoscopy for routinely accepted indications
• If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
• Negative pregnancy test at screening, if applicable
• In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

Exclusion criteria

• Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
• Subjects who had previous significant gastrointestinal surgeries.
• Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
• Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results
• Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
• Subjects with a prior history of renal, liver or cardiac insufficiency
• Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
• Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
• Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
• Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
• Subjects undergoing colonoscopy for foreign body removal and/or decompression.