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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-13

Study Completion Date

2024-07-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers - Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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NNC0560-0004

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

Group Type EXPERIMENTAL

NNC0560-0004

Intervention Type DRUG

NNC0560-0004, Oral administration (taken through the mouth)

Placebo (NNC0560-0004)

Participant will be randomized to receive placebo in:

Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD)

Group Type PLACEBO_COMPARATOR

Placebo (NNC0560-0004)

Intervention Type DRUG

Placebo matching NNC0560-0004, Oral administration (taken through the mouth)

Interventions

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NNC0560-0004

NNC0560-0004, Oral administration (taken through the mouth)

Intervention Type DRUG

Placebo (NNC0560-0004)

Placebo matching NNC0560-0004, Oral administration (taken through the mouth)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes