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Completed

NCT Number: NCT06133270

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.

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northwick Park Hosptial

Watford, Middlesex, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key inclusion criteria:

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

Key exclusion criteria:

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

Treatment and study plan

NNC0560-0004

Drug

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

Placebo (NNC0560-0004)

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.