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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. | Clinical Trials | Clareo Health

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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.

A Phase I, Randomised, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Once-daily Oral Doses of NNC0560-0004 in Healthy Humans, With an Additional Open Label Single Dose Cohort of CYP2D6 Poor Metabolizers.

NCT06133270•Novo Nordisk A/S

View on ClinicalTrials.gov

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 by chance. This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans. The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks. Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Female, of non-childbearing potential, or male, both genders aged 18-55 years (both inclusive) at the time of signing informed consent.
•2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m\^2 (both inclusive) at screening.
•3. 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
•4. CYP2D6 phenotype:
•1. For Part A and Part B: ultra-rapid (from cohort A3 forward and B1 forward), normal or intermediate CYP2D6 function
•2. For Part C: CYP2D6 Poor Metaboliser function

Exclusion Criteria

•1. Any disorder/condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
•2. Known history of histamine intolerance or severe anaphylactic reactions
•3. 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).
•4. CYP2D6 unknown phenotype

Locations (1)

Northwick Park Hosptial

Watford, Middlesex, United Kingdom

Key Dates

Start Date

November 13, 2023

Primary Completion Date

July 4, 2024

Completion Date

July 4, 2024

Last Updated

August 20, 2025

Enrollment

ACTUAL participants

Conditions

Healthy Volunteers - Liver Diseases

Interventions

NNC0560-0004

DRUG

Placebo (NNC0560-0004)

DRUG