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.

Phase 1

Completed

• Conditions: Healthy Volunteers - Liver Diseases

• Registration Number: NCT06133270
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Key inclusion criteria:<br><br> 1. Female, of non-childbearing potential, or male, both genders aged 18-55 years (both<br> inclusive) at the time of signing informed consent.<br><br> 2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive) at screening.<br><br> 3. Considered to be generally healthy based on the medical history, physical<br> examination, and the results of vital signs, electrocardiogram and clinical<br> laboratory tests including inflammatory markers performed during the screening<br> visit, as judged by the investigator<br><br> 4. CYP2D6 phenotype:<br><br> 1. For Part A and Part B: ultra-rapid (from cohort A3 forward and B1 forward),<br> normal or intermediate CYP2D6 function<br><br> 2. For Part C: CYP2D6 Poor Metaboliser function<br><br>Key exclusion criteria:<br><br> 1. Any disorder/condition, which in the investigator's opinion might jeopardise<br> participant's safety or compliance with the protocol.<br><br> 2. Known history of histamine intolerance or severe anaphylactic reactions<br><br> 3. Abnormal values at screening for any of the following laboratory parameters<br><br> - Aspartate aminotransferase (AST) greater than Upper limit of normal (ULN)+10%.<br><br> - Alanine aminotransferase (ALT) greater than ULN +10%.<br><br> - Bilirubin (except if known Gilbert's syndrome) greater than ULN +10%.<br><br> - Creatinine greater than ULN.<br><br> a.eGFR below 90 ml/min/1.73m^2<br><br> - Glycated haemoglobin (HbA1c) greater than or equal to 5.7% (39 mmol/mol).<br><br> 4. CYP2D6 unknown phenotype

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part A: Number of treatment-emergent adverse events (TEAE);Part B: Number of treatment-emergent adverse events (TEAE);Part C: Number of treatment-emergent adverse events (TEAE)