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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917938
• Other study ID #: NN9500-4621
• Secondary ID: 2022-001835-10U1
• Status: Recruiting
• Phase: Phase 1
• Start date: July 5, 2023
• Est. completion date: August 17, 2024

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: August 17, 2024
• Est. primary completion date: August 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• NNC0194-0499
NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection.

Locations

Country	Name	City	State
Germany	APEX Research	München
Poland	Uniwersyteckie Centrum Kliniczne (UCK)	Gdansk
Slovakia	Summit Clinical Research s.r.o.	Bratislava
Slovakia	Summit Clinical Research s.r.o.	Malacky

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-8, 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).	From 0 hours (Day 1) until end of study visit (Day 36)
Secondary	Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum	Measured in nanomoles per liter (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 in serum	Measured in hours.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499	Measured in liters per hour.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary	Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose	Measured in liters.	From Day 1 (pre-dose) until completion of the end of trial visit (Day 36)
Secondary	Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36)