A Phase 1 interventional study of PLENVU powder for oral solution in Pharmacokinetic, sponsored by Norgine. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by Norgine · Phase 1, Interventional, and Treatment
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This study characterises the pharmacokinetic (PK) profile of the active ingredients of PLENVU (NER1006) and their related substances/metabolites. Subjects will receive PLENVU.
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).
Norgine is the lead sponsor of 54 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: PLENVU powder for oral solution
Drug pages: Polyethylene glycol 3350 · PEG-based Laxative NER1006
PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)
Also known as: NER1006
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.
Time frame: 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.
Time frame: 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.
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 (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.
Time frame: 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.
Time frame: 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.
Time frame: Blood samples were taken pre-dose and up to 60 hours after start of Dose 1
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.
Time frame: 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). A. 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
Time frame: Start of dose 1 to 60 hours
| Milestone | Overall Study |
|---|---|
| Started | 19 |
| Completed | 13 |
| Not completed | 6 |
| Withdrew: Protocol violation | 6 |
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.
| hours | Overall Study |
|---|---|
| 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) |
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.
| hours | Overall Study |
|---|---|
| PEG 3350 | 3.58 ± 14.3 |
| Glycolic acid | 4.63 ± 0 |
| Ascorbic acid | 11.62 ± 270 |
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.
| ng/mL | Overall Study |
|---|---|
| PEG 3350 | 1010 ± 42.5 |
| Glycolic acid | 528 ± 113.0 |
| Ascorbic Acid (μg/mL) | 59.1 ± 26.1 |
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.
| ng.h/mL | Overall Study |
|---|---|
| PEG 3350 | 7220 ± 31.7 |
| Glycolic acid | 3820 ± 53.1 |
| Ascorbic acid (μg.h/mL) | 359 ± 17.3 |
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.
| ng.h/mL | Overall Study |
|---|---|
| PEG 3350 | 7140 ± 32.2 |
| Glycolic acid | 9020 ± 51.5 |
| Ascorbic acid (μg.h/mL) | 437 ± 24.0 |
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.
| ng.h/mL | Overall Study |
|---|---|
| PEG 3350 | 7340 ± 31.1 |
| Gycolic acid | 6900 ± 0 |
| Ascorbic acid (μg.h/mL) | 397 ± 23.9 |
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.
| Participants | Overall Study |
|---|---|
| 0-6 hours — 0 bowel movements | 0 |
| 0-6 hours — 1 bowel movement | 0 |
| 0-6 hours — 2 bowel movements | 1 |
| 0-6 hours — 3 bowel movements | 0 |
| 0-6 hours — 4 bowel movements | 1 |
| 0-6 hours — 5 bowel movements | 2 |
| 0-6 hours — 6 bowel movements | 1 |
| 0-6 hours — 7 bowel movements | 4 |
| 0-6 hours — 8 bowel movements | 0 |
| 0-6 hours — 9 bowel movements | 1 |
| 0-6 hours — ≥10 bowel movements | 3 |
| 6 - 12 hours — 0 bowel movements | 1 |
| 6 - 12 hours — 1 bowel movement | 4 |
| 6 - 12 hours — 2 bowel movements | 4 |
| 6 - 12 hours — 3 bowel movements | 4 |
| 6 - 12 hours — 4 bowel movements | 0 |
| 6 - 12 hours — 5 bowel movements | 0 |
| 6 - 12 hours — 6 bowel movements | 0 |
| 6 - 12 hours — 7 bowel movements | 0 |
| 6 - 12 hours — 8 bowel movements | 0 |
| 6 - 12 hours — 9 bowel movements | 0 |
| 6 - 12 hours — ≥10 bowel movements | 0 |
| 12 - 24 hours — 0 bowel movements | 10 |
| 12 - 24 hours — 1 bowel movement | 3 |
| 12 - 24 hours — 2 bowel movements | 0 |
| 12 - 24 hours — 3 bowel movements | 0 |
| 12 - 24 hours — 4 bowel movements | 0 |
| 12 - 24 hours — 5 bowel movements | 0 |
| 12 - 24 hours — 6 bowel movements | 0 |
| 12 - 24 hours — 7 bowel movements | 0 |
| 12 - 24 hours — 8 bowel movements | 0 |
| 12 - 24 hours — 9 bowel movements | 0 |
| 12 - 24 hours — ≥10 bowel movements | 0 |
| 24 - 48 hours — 0 bowel movements | 10 |
| 24 - 48 hours — 1 bowel movement | 3 |
| 24 - 48 hours — 2 bowel movements | 0 |
| 24 - 48 hours — 3 bowel movements | 0 |
| 24 - 48 hours — 4 bowel movements | 0 |
| 24 - 48 hours — 5 bowel movements | 0 |
| 24 - 48 hours — 6 bowel movements | 0 |
| 24 - 48 hours — 7 bowel movements | 0 |
| 24 - 48 hours — 8 bowel movements | 0 |
| 24 - 48 hours — 9 bowel movements | 0 |
| 24 - 48 hours — ≥10 bowel movements | 0 |
| 48 - 60 hours — 0 bowel movements | 10 |
| 48 - 60 hours — 1 bowel movement | 3 |
| 48 - 60 hours — 2 bowel movements | 0 |
| 48 - 60 hours — 3 bowel movements | 0 |
| 48 - 60 hours — 4 bowel movements | 0 |
| 48 - 60 hours — 5 bowel movements | 0 |
| 48 - 60 hours — 6 bowel movements | 0 |
| 48 - 60 hours — 7 bowel movements | 0 |
| 48 - 60 hours — 8 bowel movements | 0 |
| 48 - 60 hours — 9 bowel movements | 0 |
| 48 - 60 hours — ≥10 bowel movements | 0 |
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). A. 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
| minutes | Overall Study |
|---|---|
| Time to clear effluent (A) | 226.0 (98 to 310) |
| Time to turbid contents (B) | 165.5 (58 to 410) |
Collected over Screening (Day -28 to -2) to post study follow-up (Day 6 to 8). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study | 0/19 (0%) | 0/19 (0%) | 19/19 (100%) |
| Event | Overall Study |
|---|---|
| DiarrhoeaGastrointestinal disorders | 19/19 |
| NauseaGastrointestinal disorders | 8/19 |
| ProctalgiaGastrointestinal disorders | 3/19 |
| VomitingGastrointestinal disorders | 3/19 |
| Feeling hotGeneral disorders | 1/19 |
| HeadacheNervous system disorders | 1/19 |
| Rectal haemorrhageGastrointestinal disorders | 1/19 |
Healthy adult subjects who recieved at least a partial dose of PLENVU
| Age, Categorical(Participants) | Overall Study |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 0 |
| Age, Continuous(years) | Overall Study |
|---|---|
| Median | 25.0 (19 to 29) |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 9 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Overall Study |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Overall Study |
|---|---|
| United Kingdom | 19 |
| BMI(kg/m2) | Overall Study |
|---|---|
| Mean | 24.85 ± 3.896 |
| Height(cm) | Overall Study |
|---|---|
| Mean | 171.5 ± 10.92 |
| Weight(kg) | Overall Study |
|---|---|
| Mean | 73.82 ± 17.011 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2020 to primary completion in Oct 2020, 1 month.
Results were first posted in Nov 2021, 1 year after primary completion.
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Studies of the drugs tested here: Polyethylene glycol 3350 · PEG-based Laxative NER1006