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

Non-alcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722653
• Other study ID #: NN9500-4663
• Secondary ID: U1111-1255-1392
• Status: Completed
• Phase: Phase 1
• Start date: February 2, 2021
• Est. completion date: April 27, 2021

Study information

• Verified date: April 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• NNC0194-0499
1 single dose administered subcutaneously (s.c. - under the skin)
• Placebo (NNC0194-0499 )
1 single dose administered subcutaneously (s.c. - under the skin).

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)	Count of events	From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)
Secondary	AUC0-8, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration	h·nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	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	h·nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	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	h·nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration	nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration	Hours	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	t½, SD: Terminal half-life of NNC0194-0499	Hours	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	CL/FSD: Apparent total serum clearance of NNC0194-0499	L/h	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Vz/FSD: Apparent volume of distribution of NNC0194-0499 in the terminal phase	L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration	Hours	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)