PharmacokineticPhase 1PKPUNCT03437265

A Pharmacokinetic Study of PLENVU® in Healthy Subjects

A Phase 1 study testing PLENVU powder for oral solution in people with Pharmacokinetic, run by Norgine at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetic
What is being tested?: PLENVU powder for oral solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited Kingdom
Study dates: 3 Sep 2020to 5 Oct 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males or non-pregnant, non-lactating healthy females
Age 18 to 30 years
BMI of 18.0 to 35.0 kg/m2
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent
Must agree to use an adequate method of contraception

Who cannot join

Subjects who have received any Investigational Medicinal Product (IMP) in a clinical research study within the previous 3 months
Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Subjects who have previously been enrolled in this study.
History of any drug or alcohol abuse in the past 2 years
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)
Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening

Show all 26Show fewer

Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Females who are pregnant or lactating (all female subjects must have a negative urine pregnancy test at screening and admission).
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator at screening
Evidence of dehydration or abnormal electrolyte levels. Clinical evidence or suspicion of significant dehydration at admission/pre-dose.
History or evidence of any clinically relevant ECG abnormality and hypertension
Positive drugs of abuse test result
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or psychiatric disorder, as judged by the investigator
History or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, inflammatory bowel disease or irritable bowel syndrome)
Previous or current relevant abnormal gastrointestinal motility according to clinical judgement
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
History of any of the contraindications mentioned in the PLENVU Summary of Product Characteristics (SmPC)
Clinically relevant findings on physical examination based on investigator judgement
Donation or loss of greater than 500 mL of blood within the previous 8 weeks
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.
Use of laxatives and gastrointestinal motility altering drug in the last 3 months
Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Subjects who are ordered to live in an institution on court or authority order
Failure to satisfy the investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Sciences (Quotient),
Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

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

Read the 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
Being tested: PLENVU powder for oral solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PLENVU powder for oral solutionDrug
Also called NER1006
PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)

Study groups in NCT03437265
Study group	Role	What they receive
PLENVU powder for oral solution	Experimental	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. Receives: Drug: PLENVU powder for oral solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Tmax (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Time of maximum observed concentration (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the pharmacokinetic (PK) population.
Measured: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
T1/2 (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Apparent elimination half-life (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
Measured: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
Cmax (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
The mean maximum observed concentration (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
Measured: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
Area Under the Curve From 0 Time to 24 h Post-dose (AUC[0-24]) (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Area under the curve from 0 time to 24 h post-dose (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
Measured: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
AUC(0-last) (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Area under the curve from 0 time to the last measurable concentration (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
Measured: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
AUC(0-inf) (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Area under the curve from 0 time extrapolated to infinity (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
Measured: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1

Secondary outcomes (2)

Timing and Number of Bowel Movements
Pharmacodynamic outcome. The time of each bowel movement will be recorded for each subject, and the number of bowel movements after each dose per subject will be derived.
Measured: Start of dose 1 to 60 hours
Time to Achieve Clear Effluent
Pharmacodynamic outcome. Scoring was according to a 4-point scale (adapted from the stool characteristics rating tool described by Hsu et al, Adv Dig Med. 2016; 3 (3):144-147).
1. Clear contents (may be coloured but able to visualise the bottom of the toilet bowl) B. Turbid contents C. Opaque contents (dark and murky) D. Any solid/semi-solid faecal material (irrespective of size) in the toilet bowl
Measured: Start of dose 1 to 60 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 20205 Oct 2020

First posted19 Feb 2018
Study start3 Sep 2020
Primary completion5 Oct 2020
Study completion5 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacokineticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03437265
Sponsor's protocol ID: NER1006-03/2016 (PKPU)
Other IDs: 2017-003440-20, 2017
Acronym: PKPU
Status last verified: Nov 2023
First submitted: 16 Jan 2018
Last updated: 29 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetic Study of PLENVU® in Healthy Subjects
ClinicalTrials.gov ID: NCT03437265
Acronym / sponsor ID: PKPU / NER1006-03/2016 (PKPU)
Conditions: Pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: NorgineIndustry (pharma, biotech, devices)
Collaborators: Quotient Sciences
Study start: 3 Sep 2020 (actual)
Primary completion: 5 Oct 2020 (actual)
Study completion: 5 Oct 2020 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 3 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PLENVU powder for oral solution	Experimental	Drug: PLENVU powder for oral solutionDose 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.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy males or non-pregnant, non-lactating healthy females
Age 18 to 30 years
BMI of 18.0 to 35.0 kg/m2
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent

Key exclusion criteria (26 listed)

Subjects who have received any Investigational Medicinal Product (IMP) in a clinical research study within the previous 3 months
Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Subjects who have previously been enrolled in this study.
History of any drug or alcohol abuse in the past 2 years
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PLENVU powder for oral solutionAlso: NER1006PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)	Drug	PLENVU powder for oral solution

Primary outcome

Tmax (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
Time of maximum observed concentration (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the pharmacokinetic (PK) population.
T1/2 (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
Apparent elimination half-life (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
Cmax (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
The mean maximum observed concentration (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
Area Under the Curve From 0 Time to 24 h Post-dose (AUC[0-24]) (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
Area under the curve from 0 time to 24 h post-dose (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
AUC(0-last) (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
Area under the curve from 0 time to the last measurable concentration (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.
AUC(0-inf) (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)
Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
Area under the curve from 0 time extrapolated to infinity (of PEG3350, and glycolic acid and ascorbic acid corrected for baseline levels), calculated from individual plasma concentrations of the PK population.

2 secondary outcomes

Timing and Number of Bowel Movements
Time frame: Start of dose 1 to 60 hours
Time to Achieve Clear Effluent
Time frame: Start of dose 1 to 60 hours

Results and safety

Results posted to the registry on 3 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study	19	13

Primary outcome: Tmax (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)

Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1. Median (Full Range). Unit: hours

Measure	Overall Study n = 13
PEG 3350	3.00 (1.97 to 4.03)
Glycolic acid	9.00 (4.00 to 36.07)
Ascorbic acid	5.00 (4.00 to 6.00)

Population analysed: PK population 1: all evaluable subjects who had a minimum of 1 valid post-dose analytical result for PK parameter estimation and who satisfied the following criterion for at least 1 profile: no relevant protocol deviations which may have impacted the study objectives with respect to the PK endpoints.

Primary outcome: T1/2 (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)

Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1. Geometric mean (Geometric Coefficient of Variation). Unit: hours

Measure	Overall Study n = 13
PEG 3350	3.58 (14.3)
Glycolic acid	4.63 (0)
Ascorbic acid	11.62 (270)

Primary outcome: Cmax (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)

Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Overall Study n = 13
PEG 3350	1010 (42.5)
Glycolic acid	528 (113.0)
Ascorbic Acid (μg/mL)	59.1 (26.1)

Primary outcome: Area Under the Curve From 0 Time to 24 h Post-dose (AUC[0-24]) (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid)

Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1. Geometric mean (Geometric Coefficient of Variation). Unit: ng.h/mL

Measure	Overall Study n = 13
PEG 3350	7220 (31.7)
Glycolic acid	3820 (53.1)
Ascorbic acid (μg.h/mL)	359 (17.3)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening (Day -28 to -2) to post study follow-up (Day 6 to 8). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Study	0 of 19 (0%)	19 of 19 (100%)	0 of 19

Limitations and caveats (from the sponsor): In addition to PEG 3350, glycolic acid and ascorbic acid, PK parameters were to be determined for oxalic acid, ethylene glycol and diethylene glycol. However, this was not done, as no quantifiable concentrations of oxalic acid (LLOQ \<10.0 μg/mL), diethylene glycol (LLOQ \<2.50 μg/mL), or ethylene glycol (LLOQ \<2.50 μg/mL) were observed. Diarrhoea was expected as it is the intended pharmacodynamic effect of PLENVU bowel preparation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Evans, MBChB, MRCS principal investigator

Quotient Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PLENVU powder for oral solution in people with Pharmacokinetic, run by Norgine at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tmax (PEG 3350, Baseline-corrected Glycolic Acid and Baseline-corrected Ascorbic Acid) (time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.