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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Norgine

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