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

Conditions: Colon Cancer

Summary: a study to assess the pharmacodynamics, safety and tolerability of a peg-based bowel cleansing solution (moviprep®)


Eligibility criteria:
inclusion criteria: * 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 subject: 1. is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia,or 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 instructions. * ferrous sulphate should be stopped at least one week prior to study medication. exclusion criteria: * 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 \[ibs\]). * 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 investigational drug. * 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 judgement. * 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) at screening. * 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 check-in evaluations. * 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 significantly. * previous participation in the study. * persons who are ordered to live in an institution on court or authority order