Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy
- The subject's written informed consent must be obtained prior to inclusion.
- Subjects age 40 to 70 years.
- Part B only: Subjects willing to undergoing a screening colonoscopy, where the
1. is between 40 and 70 years of age and has a known personal or familial risk of
2. is aged 55 to 70.
- Part A: Subjects need to be without any history of clinically significant
gastrointestinal symptoms by clinical judgement and without the presence of acute
abdominal discomfort or symptoms.
- Females of child bearing potential must be surgically sterile, post- menopausal,
practicing true sexual abstinence or using an acceptable form of effective
contraception throughout the study from the following list: contraceptive injections,
implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices
(IUDs), vasectomised partner or barrier method (condom or occlusive cap) with
spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must
also use additional contraception. Hormonal and IUD methods of contraception must be
established for a period of 3 months prior to dosing and cannot be changed or altered
during the study. All females must have a negative pregnancy test at screening and
check-in (unless post-menopausal).
- Willing, able and competent to complete the entire procedure and to comply with study
- Ferrous sulphate should be stopped at least one week prior to study medication.
- Part A only: Subjects undergoing screening colonoscopy.
- Presence of current clinically significant functional gastrointestinal (GI) disorder
(e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome
- Regular use of laxatives or colon motility altering drugs in the last month.
- Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of
- Any history or current presence of ileus, gastrointestinal (GI) obstruction or
perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
- Known glucose-6-phosphatase dehydrogenase deficiency.
- Known phenylketonuria.
- History or evidence of any clinical significant cardiovascular or neurological
disease, cardiac, renal or hepatic insufficiency.
- Known hypersensitivity to polyethylene glycols and/or ascorbic acid.
- History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities
and/or uncontrolled hypertension.
- Evidence of dehydration.
- Any evidence for clinically significant abnormal sodium or potassium levels or other
clinically significant plasma electrolyte disturbances.
- Females who are not post-menopausal with a positive pregnancy test. Females not using
reliable methods of birth control if not post-menopausal.
- Clinically relevant findings on physical examination based on the Investigator's
- Clinically relevant deviations of laboratory parameters from reference ranges at
screening or check-in evaluation.
- Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV)
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of
such abuse as indicated by the laboratory assays conducted during the screening or
- Subjects who are unwilling to comply with the provisions of the study protocol.
- Concurrent participation in an investigational drug study or participation within 3
months of study entry.
- Subject has a condition or is in a situation, which in the Investigator's opinion may
put the subject at significant risk, may confound the study results, or may interfere
- Previous participation in the study.
- Persons who are ordered to live in an institution on court or authority order