Phase
Condition
Primary Biliary Cholangitis
Treatment
Placebo (NNC0560-0004)
NNC0560-0004
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key inclusion criteria:
Female, of non-childbearing potential, or male, both genders aged 18-55 years (bothinclusive) at the time of signing informed consent.
Body Mass Index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive) at screening.
Considered to be generally healthy based on the medical history, physicalexamination, and the results of vital signs, electrocardiogram and clinicallaboratory tests including inflammatory markers performed during the screeningvisit, as judged by the investigator
CYP2D6 phenotype:
For Part A and Part B: ultra-rapid (from cohort A3 forward and B1 forward),normal or intermediate CYP2D6 function
For Part C: CYP2D6 Poor Metaboliser function
Exclusion
Key exclusion criteria:
Any disorder/condition, which in the investigator's opinion might jeopardiseparticipant's safety or compliance with the protocol.
Known history of histamine intolerance or severe anaphylactic reactions
Abnormal values at screening for any of the following laboratory parameters
Aspartate aminotransferase (AST) greater than Upper limit of normal (ULN)+10%.
Alanine aminotransferase (ALT) greater than ULN +10%.
Bilirubin (except if known Gilbert's syndrome) greater than ULN +10%.
Creatinine greater than ULN.a.eGFR below 90 ml/min/1.73m^2
Glycated haemoglobin (HbA1c) greater than or equal to 5.7% (39 mmol/mol).
- CYP2D6 unknown phenotype
Study Design
Connect with a study center
Northwick Park Hosptial
Watford, Middlesex HA1 3UJ
United KingdomSite Not Available
Novo Nordisk Investigational Site
Watford, Middlesex HA1 3UJ
United KingdomActive - Recruiting
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