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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers - Liver Diseases
• Intervention / Treatment: Drug: NNC0560-0004; Drug: Placebo (NNC0560-0004)

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Watford, Middlesex, United Kingdom, HA1 3UJ
      • Northwick Park Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: NNC0560-0004; NNC0560-0004, Oral administration (taken through the mouth)
Placebo Comparator: Placebo (NNC0560-0004); Participant will be randomized to receive placebo in: Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD)	Drug: Placebo (NNC0560-0004); Placebo matching NNC0560-0004, Oral administration (taken through the mouth)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Number of treatment-emergent adverse events (TEAE)	Number of events	From pre-dose (day 1) to end of study, Part A (up to day 13)
Part B: Number of treatment-emergent adverse events (TEAE)	Number of events	From pre-dose (day 1) to end of study, Part B (up to day 26)
Part C: Number of treatment-emergent adverse events (TEAE)	Number of events	From pre-dose (day 1) to end of study, Part C (up to day 84)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose	h*nmol/L	From pre-dose (day 1) to end of study, Part A (up to day 13)
Part A: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose	nmol/L	From pre-dose (day 1) to end of study, Part A (up to day 13)
Part A: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose	hour	From pre-dose (day 1) to end of study, Part A (up to day 13)
Part A:t½, SD: the terminal half-life of NNC0560-0004 after a single dose	hour	From pre-dose (day 1) to end of study, Part A (up to day 13)
Part B: AUC0-24h, MD: the area under the NNC0560-0004 plasma concentration-time curve in the dosing interval after last dosing	h*nmol/L	From pre-dose on day 14 until end of study, Part B (up to day 26) (24 hours post-dose)
Part B: Cmax, MD: the maximum plasma concentration of NNC0560-0004 after last dosing	nmol/L	From pre-dose on day 14 to end of study, Part B (up to day 26)
Part B:tmax, MD: the time to maximum concentration of NNC0560-0004 after last dosing	hour	From pre-dose on day 14 to end of study, Part B (up to day 26)
Part B:t½, MD: the terminal half-life of NNC0560-0004 after last dosing	hour	From pre-dose on day 14 to end of study, Part B (up to day 26)
Part C: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose	h*nmol/L	From pre-dose (day 1) to end of study, Part C (up to day 84)
Part C: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose	nmol/L	From pre-dose (day 1) to end of study, Part C (up to day 84)
Part C: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose	hour	From pre-dose (day 1) to end of study, Part C (up to day 84)
Part C: t½, SD: the terminal half-life of NNC0560-0004 after a single dose	hour	From pre-dose (day 1) to end of study, Part C (up to day 84)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): July 4, 2024
• Study Completion (Actual): July 4, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: NN6561-7567; U1111-1285-1593 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No