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.

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers - Liver Diseases

Treatments: Drug: Placebo (NNC0560-0004); Drug: NNC0560-0004

Study type: Interventional

Funder types: Industry

Identifiers

NCT06133270

U1111-1285-1593 (Other Identifier)

NN6561-7567

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

NNC0560-0004

Experimental group

Description:

The study will be conducted in 3 parts. Participants will be randomized to receive NNC0560-0004 in Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) No randomisation - only active treatment in Part C: Single dose

Treatment:

Drug: NNC0560-0004

Placebo (NNC0560-0004)

Placebo Comparator group

Description:

Participant will be randomized to receive placebo in: Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD)

Treatment:

Drug: Placebo (NNC0560-0004)