Clinical trial · Interventional
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
NCT01714466CI-TRIAL-00016118completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MOVIPREP | Drug | — | UNRESOLVED |
| NER1006 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Part A, arm 1
- description
- Evening dose of TF048. Morning dose of TF043
- interventionNames
- Drug: NER1006
- type
- EXPERIMENTAL
- label
- Part A, arm 2
- description
- Evening dose of TF043. Morning dose of TF048
- interventionNames
- Drug: NER1006
- type
- EXPERIMENTAL
- label
- Part A, arm 3
- description
- Evening dose of TF047. Morning dose of TF043
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDClayton LB, Tayo B, Halphen M, Kornberger R. Novel 1 L polyethylene glycol-based bowel preparation (NER1006): proof of concept assessment versus standard 2 L polyethylene glycol with ascorbate - a randomized, parallel group, phase 2, colonoscopist-blinded trial. BMC Gastroenterol. 2019 May 30;19(1):79. doi: 10.1186/s12876-019-0988-y. PMID 31146679