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Completed

NCT Number: NCT04722653

A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men

This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men.

Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499.

Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach.

The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).

The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.

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Key information

Conditions

Non-alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Tokyo, 130-0004, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male, aged 20-55 years (both inclusive) at the time of signing informed consent
  • For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent
  • Body mass index (BMI) between 23.0 and 34.9 kg/m^2 (both inclusive)
  • Body weight greater than or equal to 60 kg

Exclusion criteria

  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
  • Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage

Treatment and study plan

NNC0194-0499

Drug

1 single dose administered subcutaneously (s.c. - under the skin)

Placebo (NNC0194-0499 )

Drug

1 single dose administered subcutaneously (s.c. - under the skin).

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

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

    Count of events

Secondary outcomes

  1. AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration

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

    h·nmol/L

  2. AUC0-tz, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time of the last quantifiable sample after a single s.c. administration

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

    h·nmol/L

  3. AUC0-168h, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration

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

    h·nmol/L

  4. Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration

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

    nmol/L

  5. tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration

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

    Hours

  6. t½, SD: Terminal half-life of NNC0194-0499

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

    Hours

  7. CL/FSD: 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)

    L/h

  8. Vz/FSD: 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)

    L

  9. MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration

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

    Hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2021
Registry last updated
Apr 5, 2022

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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