Status:
COMPLETED
A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers - Liver Diseases
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers. Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Female, of non-childbearing potential, or male, both genders aged 18-55 years (both inclusive) 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, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests including inflammatory markers performed during the screening visit, 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
- Key exclusion criteria:
- Any disorder/condition, which in the investigator's opinion might jeopardise participant'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
Exclusion
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06133270
Start Date
November 13 2023
End Date
July 4 2024
Last Update
August 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwick Park Hosptial
Watford, Middlesex, United Kingdom, HA1 3UJ