Clinical trial NCT04722653: A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men
Official title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-01-25
Enrollment: 42
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present trial is split into two parts reflecting the two trial populations: Japanese subjects and non-Asian subjects. For the Japanese part, it is designed as a randomised, placebo-controlled, double-blinded within cohorts, parallel group, single-dose trial. The non-Asian part is run in parallel to the Japanese part in an open design
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)
Secondary outcomes:
measure: AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: 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
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: 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
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: t½, SD: 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/FSD: 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/FSD: 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: MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: