Back to resultsA Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
NNC0194-0499
NNC0194-0499
NC0194-0499
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease
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.
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
NNC0194-0499 12 mg
NNC0194-0499 30 mg
NNC0194-0499 96 mg
Arm Description
Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1.
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
Outcomes
Primary Outcome Measures
AUC0-∞, 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).
Secondary Outcome Measures
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.
Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum
Measured in nmol/L.
tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499
Measured in hours.
t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499
Measured in hours.
CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499
Measured in liters per hour (L/h).
Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase
Measured in liters (L).
Relative change in triglycerides
Measured in Percent change.
Relative change in high-density lipoprotein (HDL) cholesterol
Measured in Percent change.
Relative change in low-density lipoprotein (LDL) cholesterol
Measured in Percent change.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05742919
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
June 13, 2023 (Actual)
Study Completion Date
June 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC0194-0499 12 mg
Arm Type
Experimental
Arm Description
Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1.
Arm Title
NNC0194-0499 30 mg
Arm Type
Experimental
Arm Description
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Arm Title
NNC0194-0499 96 mg
Arm Type
Experimental
Arm Description
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
Intervention Type
Drug
Intervention Name(s)
NNC0194-0499
Intervention Description
Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.
Intervention Type
Drug
Intervention Name(s)
NNC0194-0499
Intervention Description
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Intervention Type
Drug
Intervention Name(s)
NC0194-0499
Intervention Description
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
Primary Outcome Measure Information:
Title
AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
Description
Measured in nanomoles*hours per liter (nmol h/L).
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary Outcome Measure Information:
Title
AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose
Description
Measured in nmol h/L.
Time Frame
From Day 1 (pre-dose) until Day 7 (168 hours)
Title
Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum
Description
Measured in nmol/L.
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499
Description
Measured in hours.
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499
Description
Measured in hours.
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499
Description
Measured in liters per hour (L/h).
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase
Description
Measured in liters (L).
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
Relative change in triglycerides
Description
Measured in Percent change.
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
Relative change in high-density lipoprotein (HDL) cholesterol
Description
Measured in Percent change.
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
Relative change in low-density lipoprotein (LDL) cholesterol
Description
Measured in Percent change.
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency dept. 2834
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250062
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men
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