A Pharmacokinetic Study of PLENVU® in Healthy Subjects

NCT ID: NCT03437265

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2020-10-05

Brief Summary

This study characterises the pharmacokinetic (PK) profile of the active ingredients of PLENVU (NER1006) and their related substances/metabolites. Subjects will receive PLENVU.

Detailed Description

PLENVU is a novel, low volume (1 L) PEG 3350 and ascorbate based bowel preparation that has been developed to provide whole bowel cleansing. Studies have shown that formulating the osmotically active agents sodium ascorbate/ascorbic acid (also known as vitamin C) and sodium sulfate in combination with PEG 3350 enable a reduction in the volume of the PEG-based lavage solution.

PLENVU has a dual formulation containing an initial majority PEG dose followed by a majority ascorbate dose to maximise the overall effectiveness. This novel formulation addresses the challenges faced by patients to comply with drinking higher volume, 2 and 3 L, preparations.

The purpose of this study is to determine if there is systemic exposure to components of the PLENVU formulation (PEG 3350, ascorbate and potential related substances/metabolites (oxalic acid, glycolic acid, ethylene glycol and diethylene glycol).

Conditions

Pharmacokinetic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLENVU powder for oral solution

Dose 1: Oral administration of 1 sachet (115.96 g) PLENVU Dose 1, reconstituted with water and made up to 473 mL and 473 mL of additional water to be consumed; both to be consumed over a period of 60 min after the start of Dose 1.

Dose 2: Oral administration of 2 sachets (101.91 g) comprising PLENVU Dose 2, reconstituted with water and made up to 473 mL and 473 mL of additional water to be consumed; both to be consumed over a period of 60 min after the start of Dose 2.

Additional water was permitted ad libitum during and after each dose.

Group Type: EXPERIMENTAL

PLENVU powder for oral solution

Intervention Type: DRUG

PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)

Interventions

PLENVU powder for oral solution

PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)

Intervention Type: DRUG

Other Intervention Names

NER1006

Eligibility Criteria

Inclusion Criteria

1. Healthy males or non-pregnant, non-lactating healthy females

2. Age 18 to 30 years

3. 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

Exclusion Criteria

1. Subjects who have received any Investigational Medicinal Product (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 (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

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

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. Clinical evidence or suspicion of significant dehydration at admission/pre-dose.

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 (e.g. 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 (SmPC)

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 use 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 severe acute respiratory syndrome coronavirus 2 (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quotient Sciences

INDUSTRY

Sponsor Role: collaborator

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Evans, MBChB, MRCS

Role: PRINCIPAL_INVESTIGATOR

Quotient Sciences

Locations

Quotient Sciences (Quotient),

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-003440-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NER1006-03/2016 (PKPU)

Identifier Type: -

Identifier Source: org_study_id