A Pharmacokinetic Study of PLENVU® in Healthy Subjects
Condition: Pharmacokinetic
Intervention: PLENVU powder for oral solution
Intervention description: PLENVU Dose 1 (1 sachet) and PLENVU Dose 2 (2 sachets)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

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