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A Pharmacokinetic Study of NER1006 in Healthy Subjects (PKPU)

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ClinicalTrials.gov Identifier: NCT03437265
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Quotient Clinical
Information provided by (Responsible Party):
Norgine

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

Condition or disease Intervention/treatment Phase
Pharmacokinetic Drug: NER1006 powder for oral solution Phase 1

Detailed Description:

NER1006 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.

NER1006 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 NER1006 formulation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of NER1006 in Healthy Subjects
Estimated Study Start Date : April 4, 2018
Estimated Primary Completion Date : April 25, 2018
Estimated Study Completion Date : April 25, 2018

Arm Intervention/treatment
Experimental: NER1006 powder for oral solution

Oral administration of 1 sachet (115.96 g) NER1006 Dose 1 (containing PEG 3350, sodium sulfate and electrolytes), to be reconstituted with water and made up to 500 mL, consumed over approximately 30 min, followed by 500 mL water, consumed over approximately 30 min. Additional water may be drunk ad libitum after the dose.

Following 1 hour rest period, oral administration of 2 sachets (101.91 g) NER1006 Dose 2 (containing sodium ascorbate, PEG 3350, ascorbic acid and electrolytes), to be reconstituted with water and made up to 500 mL, consumed over approximately 30 min, followed by 500 mL water, consumed over approximately 30 min. Additional water may be drunk ad libitum after the dose.

Drug: NER1006 powder for oral solution
NER1006 Dose 1 (1 sachet) and NER1006 Dose 2 (2 sachets)
Other Name: PLENVU




Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) [ Time Frame: Blood samples will be taken pre-dose and up to 60 hours after start of Dose 1 ]
    Analysis of PEG 3350, ascorbate and potential related substances/metabolites (ethylene glycol, diethylene glycol and their reaction products glycolic acid, diglycolic acid, glyoxylic acid, oxalic acid and 2 hydroxyethoxyacetic acid)

  2. Area under the curve (AUC) [ Time Frame: Blood samples will be taken pre-dose and up to 60 hours after start of Dose 1 ]
    Analysis of PEG 3350, ascorbate and potential related substances/metabolites (ethylene glycol, diethylene glycol and their reaction products glycolic acid, diglycolic acid, glyoxylic acid, oxalic acid and 2 hydroxyethoxyacetic acid)

  3. The elapsed time from first dose at which analyte was first quantifiable in a concentration vs time profile (Tlag) [ Time Frame: Blood samples will be taken pre-dose and up to 60 hours after start of Dose 1 ]
    Analysis of PEG 3350, ascorbate and potential related substances/metabolites (ethylene glycol, diethylene glycol and their reaction products glycolic acid, diglycolic acid, glyoxylic acid, oxalic acid and 2 hydroxyethoxyacetic acid)

  4. The apparent elimination half-life (T1/2) [ Time Frame: Blood samples will be taken pre-dose and up to 60 hours after start of Dose 1 ]
    Analysis of PEG 3350, ascorbate and potential related substances/metabolites (ethylene glycol, diethylene glycol and their reaction products glycolic acid, diglycolic acid, glyoxylic acid, oxalic acid and 2 hydroxyethoxyacetic acid)

  5. The time from first dose at which Cmax was apparent (Tmax) [ Time Frame: Blood samples will be taken pre-dose and up to 60 hours after start of Dose 1 ]
    Analysis of PEG 3350, ascorbate and potential related substances/metabolites (ethylene glycol, diethylene glycol and their reaction products glycolic acid, diglycolic acid, glyoxylic acid, oxalic acid and 2 hydroxyethoxyacetic acid)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males or non-pregnant, non-lactating healthy females
  2. BMI of 18.0 to 35.0 kg/m2
  3. Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  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 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. Known glucose-6-phosphatase dehydrogenase deficiency
  20. Known phenylketonuria
  21. History of clinically significant drug allergy, history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols, ascorbic acid or any other ingredients of the formulation
  22. Clinically relevant findings on physical examination based on investigator judgement
  23. Donation or loss of greater than 500 mL of blood within the previous 8 weeks
  24. 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.
  25. Use of laxatives and gastrointestinal motility altering drug in the last 3 months
  26. Subjects who are ordered to live in an institution on court or authority order
  27. Failure to satisfy the investigator of fitness to participate for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437265


Contacts
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Contact: Olga Kuehnel, MD +44 (0)1985 826 238 OKuehnel@norgine.com
Contact: Lucy Clayton +44 (0)1895 826 669 LClayton@norgine.com

Sponsors and Collaborators
Norgine
Quotient Clinical
Investigators
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Principal Investigator: Philip Evans, MBChB, MRCS (Ed) Quotient Clinical

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Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT03437265     History of Changes
Other Study ID Numbers: NER1006-03/2016 (PKPU)
2017-003440-20 ( EudraCT Number )
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharmaceutical Solutions