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Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects (OUT)

ClinicalTrials.gov ID NCT01834742
Sponsor Norgine
Information provided by Norgine (Responsible Party)
Last Update Posted 2013-04-18
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Study Overview

Brief Summary
This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.
Official Title
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects
Conditions
Colorectal Cancer
Intervention / Treatment
  • Drug: NER1006
  • Drug: NER1006
  • Drug: NER1006
  • Drug: Moviprep
    Other Study ID Numbers
    • NER1006-01/2011 (OUT)
    Study Start
    2011-04
    Primary Completion (Actual)
    2011-09
    Study Completion (Actual)
    2011-12
    Enrollment (Actual)
    161
    Study Type
    Interventional
    Phase
    Phase 1

    Contacts and Locations

    This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

    To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

    For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
    Eligibility Criteria
    Description

    Inclusion Criteria:

    1. The subject's written informed consent must be obtained prior to inclusion.
    2. Healthy subjects with an age of 18 to 45 years.
    3. Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
    4. Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in.
    5. Willing, able and competent to complete the entire procedure and to comply with study instructions.

    Exclusion Criteria:

    1. Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.
    2. Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen or metamizole).
    3. Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
    4. Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD]).
    5. Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.
    6. History or presence of any clinically significant acute illness within the 4 weeks prior to the first dose of investigational drug based on clinical judgement at screening and check-in evaluation.
    7. Known glucose-6-phosphatase dehydrogenase deficiency.
    8. Known phenylketonuria.
    9. History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction.
    10. History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid.
    11. History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension.
    12. Evidence of dehydration.
    13. Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances.
    14. Females who are pregnant, having a positive pregnancy test at screening and/or admission to unit or planning a pregnancy. Females not using reliable methods of birth control.
    15. Clinically relevant findings on physical examination based on Investigator's judgement.
    16. Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
    17. Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
    18. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.
    19. Subjects who are unwilling to comply with the provisions of the study protocol.
    20. Concurrent participation in an investigational drug study or participation within 3 month of study entry.
    21. Subject has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
    22. Previous participation in the study.
    Show less
    Ages Eligible for Study
    18 Years to 45 Years (Adult )
    Sexes Eligible for Study
    All
    Accepts Healthy Volunteers
    Yes

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

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    Design Details
    Primary Purpose : Treatment
    Allocation : Randomized
    Interventional Model : Parallel Assignment
    Masking : None (Open Label)

    Arms and Interventions

    Participant Group/Arm Intervention/Treatment
    Participant Group/Arm Experimental: Part A, arm 1
    Evening dose 1 plus fixed morning dose
    Intervention/Treatment Drug: NER1006
    • Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

    Participant Group/Arm Experimental: Part A, arm 2
    Evening dose 2 plus fixed morninf does
    Intervention/Treatment Drug: NER1006
    • Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

    Participant Group/Arm Experimental: Part A, arm 3
    Evening dose 3 plus fixed morning dose
    Intervention/Treatment Drug: NER1006
    • Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

    Participant Group/Arm Active Comparator: Part A, arm 4
    Moviprep
    Intervention/Treatment Drug: Moviprep
    • Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.

    Participant Group/Arm Experimental: Part B, arm 1
    Fixed evening dose plus morning dose 1
    Intervention/Treatment Drug: NER1006
    • Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.

    Participant Group/Arm Experimental: Part B, arm 2
    Fixed evening dose plus morning dose 2
    Intervention/Treatment Drug: NER1006
    • Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.

    Participant Group/Arm Experimental: Part B, arm 3
    Fixed evening dose plus morning dose 3
    Intervention/Treatment Drug: NER1006
    • Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.

    Participant Group/Arm Experimental: Part B, arm 4
    Fixed evening dose plus alternative morning dose
    Intervention/Treatment Drug: NER1006
    • Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.

    Primary Outcome Measures
    Outcome Measure Measure Description Time Frame
    Primary VariableStool weight output generated from the start of intake for the following 24 hours.36 Hours
    Secondary Outcome Measures
    Outcome Measure Measure Description Time Frame
    PEG3350 concentrationConcentration of PEG3350 in blood, urine and faeces.96 Hours
    Sulphate concentrationConcentration of PEG3350 in blood, urine and faeces.96 hours
    Ascorbic acid concentrationConcentration of ascorbic acid in blood, urine and faeces.96 hours
    Electrolytes concentrationConcentration of electrolytes in blood, urine and faeces.96 hours
    Safety profileSpontaneouly reported adverse events will be recorded throughout the study96 hours

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.
    Sponsor
    Norgine
    Collaborators
    • Pierrel Research Europe GmbH
    Investigators
    • Principal Investigator:Rodica Cinca, MD,Pierrel Research

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
    Study Registration Dates
    First Submitted
    2013-04-15
    First Submitted that Met QC Criteria
    2013-04-15
    First Posted (Estimated)
    2013-04-18
    Study Record Updates
    Last Update Submitted that met QC Criteria
    2013-04-15
    Last Update Posted (Estimated)
    2013-04-18
    Last Verified
    2013-04

    More Information

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    Keywords Provided by Norgine
    Additional Relevant MeSH Terms