Back to resultsA Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
Primary Purpose
Hepatic Impairment, Healthy Volunteers
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NNC0194-0499
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment
Eligibility Criteria
Inclusion Criteria: Male or female. Aged 18-80 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 18.5-39.9 kilogram per square meter (kg/m^2) (both inclusive). Specific inclusion criterion only for participants with hepatic impairment: Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator. Exclusion Criteria: Known or suspected hypersensitivity to study intervention(s) or related products. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Participants With Normal Hepatic Function
Participants With Mild Hepatic Impairment
Participants With Moderate Hepatic Impairment
Participants With Severe Hepatic Impairment
Arm Description
Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1.
Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
Outcomes
Primary Outcome Measures
AUC0-∞, Single Dose, NNC0194-0499: the area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
Measured in nanomoles hour per liter (nmol h/L).
Secondary Outcome Measures
Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum
Measured in nanomoles per liter (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 in serum
Measured in hours.
CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499
Measured in liters per hour.
Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose
Measured in liters.
Number of treatment emergent adverse events (TEAEs)
Measured as number of events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05917938
Brief Title
A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
Official Title
Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0194-0499 in Participants With Various Degrees of Hepatic Impairment and Normal Hepatic Function
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
April 17, 2024 (Anticipated)
Study Completion Date
April 17, 2024 (Anticipated)
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
The study medicine NNC0194-0499 is under development for non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH). All participants will receive a single dose of 30 milligram (mg) of the study medicine. The study medicine will be given in the form of an injection of 0.6 millilitres in a skinfold of the thigh (subcutaneous). The study will last for up to 64 days. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective contraception and will be counselled on the use of contraception. Participants with impaired liver function will undergo an ultrasound of the belly and measurement of brain activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment, Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants With Normal Hepatic Function
Arm Type
Experimental
Arm Description
Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1.
Arm Title
Participants With Mild Hepatic Impairment
Arm Type
Experimental
Arm Description
Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
Arm Title
Participants With Moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
Arm Title
Participants With Severe Hepatic Impairment
Arm Type
Experimental
Arm Description
Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
Intervention Type
Drug
Intervention Name(s)
NNC0194-0499
Intervention Description
NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection.
Primary Outcome Measure Information:
Title
AUC0-∞, Single Dose, 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 hour per liter (nmol h/L).
Time Frame
From 0 hours (Day 1) until end of study visit (Day 36)
Secondary Outcome Measure Information:
Title
Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum
Description
Measured in nanomoles per liter (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 in serum
Description
Measured in hours.
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499
Description
Measured in liters per hour.
Time Frame
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Title
Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose
Description
Measured in liters.
Time Frame
From Day 1 (pre-dose) until completion of the end of trial visit (Day 36)
Title
Number of treatment emergent adverse events (TEAEs)
Description
Measured as number of events.
Time Frame
From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female.
Aged 18-80 years (both inclusive) at the time of signing informed consent.
Body mass index (BMI) between 18.5-39.9 kilogram per square meter (kg/m^2) (both inclusive). Specific inclusion criterion only for participants with hepatic impairment:
Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
Exclusion Criteria:
Known or suspected hypersensitivity to study intervention(s) or related products.
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
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
München
ZIP/Postal Code
81241
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
83101
Country
Slovakia
Individual Site Status
Recruiting
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 Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
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