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NCT07587710

A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Liver Function and Normal Liver Function

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Eligibility criteria expanded, about 5 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Site details revised at 2 of 2 sites
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

AUC0-∞: The area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Timeframe: From pre-dose on Day 1 up to Day 28

Secondary (6)

Cmax: Maximum observed plasma NNC0487-0111 concentration after a single dose
tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single dose
t½,: Terminal half-life for NNC0487-0111 after a single dose
Vz/F: Apparent volume of distribution of NNC0487-0111 after a single dose
CL/F: Apparent clearance of NNC0487-0111 after a single dose
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Number of treatment emergent adverse events (TEAEs)

Arms and interventions

Severe hepatic impairmentExperimental

Participants will receive single dose of NNC0487-0111 subcutaneously.

Moderate hepatic impairmentExperimental

Participants will receive single dose of NNC0487-0111 subcutaneously.

Mild hepatic impairmentExperimental

Participants will receive single dose of NNC0487-0111 subcutaneously.

Normal hepatic impairmentExperimental

Participants will receive single dose of NNC0487-0111 subcutaneously.

Drugs: NNC0487-0111

Sites

2 sites in 1 country