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

Phase 1

Recruiting

• Conditions: Hepatic Impairment; Healthy Volunteers

• Registration Number: NCT05917938
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-6-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Inclusion Criteria:<br><br> - Male or female.<br><br> - Aged 18-80 years (both inclusive) at the time of signing informed consent.<br><br> - Body mass index (BMI) between 18.5-39.9 kilogram per square meter (kg/m^2) (both<br> inclusive). Specific inclusion criterion only for participants with hepatic<br> impairment:<br><br> - Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C<br> as assessed by the investigator. Stable hepatic impairment is defined as no<br> clinically significant change in disease status, as judged by the investigator.<br><br>Exclusion Criteria:<br><br> - Known or suspected hypersensitivity to study intervention(s) or related products.<br><br> - Female who is pregnant, breast-feeding or intends to become pregnant or is of<br> child-bearing potential and not using a highly effective contraceptive method.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum;tmax, NNC0194-0499: the time from dose administration to maximum serum concentration of NNC0194-0499;t1/2, NNC0194-0499: the terminal half-life of NNC0194-0499 in serum;CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499;Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose;Number of treatment emergent adverse events (TEAEs)