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NCT Number: NCT05742919

A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men

This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Jinan Central Hospital

Jinan, Shandong, 250062, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive).
  • Body weight greater than or equal to 60 kg.
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

  • Known or suspected hypersensitivity to study intervention or related products.
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Treatment and study plan

NNC0194-0499

Drug

Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.

NC0194-0499

Drug

Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.

Primary outcomes

  1. AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in nanomoles*hours per liter (nmol h/L).

Secondary outcomes

  1. AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose

    Time frame: From Day 1 (pre-dose) until Day 7 (168 hours)

    Measured in nmol h/L.

  2. Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in nmol/L.

  3. tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in hours.

  4. t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in hours.

  5. CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in liters per hour (L/h).

  6. Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in liters (L).

  7. Relative change in triglycerides

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in Percent change.

  8. Relative change in high-density lipoprotein (HDL) cholesterol

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in Percent change.

  9. Relative change in low-density lipoprotein (LDL) cholesterol

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in Percent change.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Jun 11, 2024

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.

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