A Pharmacokinetic Study of PLENVU® in Healthy Subjects

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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