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.

August 19, 2025 updated by: Novo Nordisk A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: Number of treatment-emergent adverse events (TEAE)
Time Frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
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)
Time Frame: From pre-dose (day 1) to end of study, Part B (up to day 26)
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)
Time Frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
Number of events
From pre-dose (day 1) to end of study, Part C (up to day 84)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
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
Time Frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
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
Time Frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
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
Time Frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
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
Time Frame: From pre-dose on day 14 until end of study, Part B (up to day 26) (24 hours post-dose)
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
Time Frame: From pre-dose on day 14 to end of study, Part B (up to day 26)
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
Time Frame: From pre-dose on day 14 to end of study, Part B (up to day 26)
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
Time Frame: From pre-dose on day 14 to end of study, Part B (up to day 26)
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
Time Frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
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
Time Frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
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
Time Frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
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
Time Frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
hour
From pre-dose (day 1) to end of study, Part C (up to day 84)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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