Intestinal failure associated liver disease (IFALD), also referred to as parenteral nutrition (PN) associated liver disease, and other potential indications. Digestive System
Conditions
Interventions
This is a non-randomised, open-label, uncontrolled study. Volunteers will receive a single dose of radiolabelled test medicine, [14C]NST 6179, as 2 capsules by mouth. They’ll stay in the clinic for up
Sponsors
NorthSea Therapeutics B.V.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent. 2. Must be willing and able to communicate and participate in the whole study. 3. Aged 30 to 65 years inclusive at the time of signing informed consent. 4. Must agree to adhere to the contraception requirements defined in the protocol. 5. Healthy males according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and clinical laboratory tests without any clinically significant abnormalities. 6. Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive, as measured at screening. 7. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day).
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients. 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active. 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator. 4. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening. 5. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in the protocol). Subjects with Gilbert’s Syndrome are not allowed. 6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results. 7. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of 21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type). 17. A confirmed positive alcohol breath test at screening or admission. 18. Current smokers and those who have smoked within the last 12 months. 19. Current us
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mass balance recovery of total radioactivity in urine, faeces and all excreta of the test medicine from the body from samples taken from Day 1 up to a maximum of Day 10 2. Pharmacokinetics and total radioactivity of the test medicine in plasma and whole blood measured in blood samples taken from Day 1 up to a maximum of Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Identify the metabolic profile (breakdown products) of the test medicine in plasma, urine and faeces in samples taken from Day 1 up to a maximum of Day 10. 2. Evaluation of whole blood:plasma concentration ratios for total radioactivity (to evaluate the extent of distribution of total radioactivity into blood cells), using samples taken between Day 1 up to a maximum of Day 10. 3. Adverse events (to assess tolerability of the test medicine) will be collected by asking volunteers how they are feeling, from the start of the trial until follow-up. Other safety measures (including vital signs, ECGs and laboratory safety tests) will also be assessed by standard phase I unit monitoring, at screening, from Day 1 to discharge from the ward. | — |
Countries
England, United Kingdom
Contacts
Public Contact. NorthSea Therapeutics B.V.
Outcome results
None listed