Clinical trial NCT05742919: A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men
Official title: Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary outcomes:
measure: AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose
timeFrame: From Day 1 (pre-dose) until Day 7 (168 hours)
measure: Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: Relative change in triglycerides
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: Relative change in high-density lipoprotein (HDL) cholesterol
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: Relative change in low-density lipoprotein (LDL) cholesterol
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: