Colon Cancer
Conditions
Brief summary
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)
Sponsors
Norgine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool weight output | 36 hours post-dose | Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours |
| Cleansing success rate | 36 hours post-dose | The cleansing success rate (grade A or B according to the Harefield Cleansing Scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cleansing scores for each colon segment | 36 hours post-dose | The segmental cleansing scores for each of the five colon segments |
| Time and volume of IMP to reach a clear effluent | 36 hours post-dose | The time and volume taken for the IMP to reach a clear effluent |
| Tolerability of medication (vomiting rate) | 36 hours post-dose | The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B |
| Electrolytes concentration | 36 hours post-dose | Concentration of electrolytes in blood, urine and faeces |
| PEG3350 concentration | 36 hours post-dose | Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities |
| Ascorbate concentration | 36 hours post-dose | Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid) |
| EQ 5D patient questionnaire outcome (Part A only) | 36 hours post-dose | Patients to use the EQ 5D patient questionnaire to assess their study medication for part A |
Countries
Germany
Outcome results
None listed