PLENVU has been developed to provide overall bowel cleansing, with an additional focus on the ascending colon. Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps. MedDRA version: 21.1 Level: PT Classification code 10066943 Term: Bowel preparation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: PLENVU Powder for Oral Solution
Product Name: PLENVU Powder for Oral Solution
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Ascorbic Acid
CAS Number: 50-81-7
Other des
Sponsors
Norgine Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males or non-pregnant, non-lactating healthy females. 2. Age 18 to 30 years 3. Body mass index (BMI) of 18.0 to 35.0 kg/m2 4. Must be willing and able to communicate and participate in the whole study 5. Must provide written informed consent 6. Must agree to use an adequate method of contraception Inclusion criteria 4 and 6 from the list above will be re-assessed at admission/pre-dose. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Subjects who have received any IMP in a clinical research study within the previous 3 months 2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee 3. Subjects who have previously been enrolled in this study. 4. History of any drug or alcohol abuse in the past 2 years 5. Regular alcohol consumption in males >21 units per week and females >14 units per week 6. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and at admission 7. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months 8. Females who are pregnant or lactating (all female subjects must have a negative urine pregnancy test at screening and admission). 9. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening 10. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator at screening 11. Evidence of dehydration or abnormal electrolyte levels 12. History or evidence of any clinically relevant ECG abnormality and hypertension 13. Positive drugs of abuse test result 14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results 15. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or psychiatric disorder, as judged by the investigator 16. History or presence of organic or functional gastrointestinal conditions (eg chronic constipation, inflammatory bowel disease or irritable bowel syndrome) 17. Previous or current relevant abnormal gastrointestinal motility according to clinical judgement 18. History or presence of any clinically significant acute illness within 28 days prior to the first dose of IMP based on clinical judgement at screening or admission 19. History of any of the contraindications mentioned in the PLENVU Summary of Product Characteristics 20. Clinically relevant findings on physical examination based on investigator judgement 21. Donation or loss of greater than 500 mL of blood within the previous 8 weeks 22. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than hormonal contraception and occasional used of non-steroidal anti inflammatory drugs [NSAIDs] and paracetamol) or herbal remedies in the 28 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor’s medical monitor. 23. Use of laxatives and gastrointestinal motility altering drug in the last 3 months 24. Evidence of current SARS-CoV-2 infection 25. Subjects who are ordered to live in an institution on court or authority order 26. Failure to satisfy the investigator of fitness to participate for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterise the Pharmacokinetic (PK) profile of key ingredients and metabolites of PLENVU (to look at how key ingredients and break down products of PLENVU move through the body).;Secondary Objective: To assess the safety, tolerability and pharmacodynamics characterisation (the effect on bowel movements) of PLENVU (1-Day Morning Only-Dosing) intake in healthy adult subjects.;Primary end point(s): PK parameters of the key active ingredients of each formulation of PLENVU, i.e. PEG3350, ascorbate and potential related substances/metabolites (oxalic acid and glycolic acid [HPLC-MS], and ethylene glycol and diethylene glycol [GC-MS]) ;Timepoint(s) of evaluation of this end point: PK plasma samples: 1h, 2h after the end of evening meal (Day-1), pre-dose, 1h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 10 h, 12 h, 16h, 20 h, 24 h, 30 h, 36 h, 48 h, 60 h post-dose one | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety parameters including: physical examination, clinical laboratory assessments, vital signs, electrocardiograms (ECGs) and AEs; and PD parameters including timing and number of bowel movements and time to clear effluent.;Timepoint(s) of evaluation of this end point: Physical examination: screening, and 60 hours post-dose one Safety laboratory tests: screening, pre-dose and 12 and 60 hours post-dose one Vital signs: screening, pre-dose, 4 h, 24 h and 60 h post-dose one Electrocardiograms (ECGs): screening, pre-dose, 4 h, 24 h and 60 h post-dose one Adverse events: On-going from admission to discharge Timing and number of bowel movements: On-going throughout the study Time to clear effluent: On-going throughout the study | — |
Countries
United Kingdom
Outcome results
None listed