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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742919
• Other study ID #: NN9500-4796
• Secondary ID: U1111-1267-4230
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2023
• Est. completion date: June 13, 2023

Study information

• Verified date: June 2024
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• NNC0194-0499
Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.
• NNC0194-0499
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
• NC0194-0499
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.

Locations

Country	Name	City	State
China	Jinan Central Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-8, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose	Measured in nanomoles*hours per liter (nmol h/L).	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose	Measured in nmol h/L.	From Day 1 (pre-dose) until Day 7 (168 hours)
Secondary	Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum	Measured in nmol/L.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499	Measured in hours.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499	Measured in hours.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499	Measured in liters per hour (L/h).	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase	Measured in liters (L).	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Relative change in triglycerides	Measured in Percent change.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Relative change in high-density lipoprotein (HDL) cholesterol	Measured in Percent change.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Relative change in low-density lipoprotein (LDL) cholesterol	Measured in Percent change.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)