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Clinical Trial Details

Trial ID: L4326
Source ID: NCT06370819
Associated Drug: Nnc0519-0130
Title: A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: NNC0519-0130
Outcome Measures: Primary: Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment, Measured in hours\* nanomoles per litre (h\*nmol/L)., From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) | Secondary: Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment, Measured in nanomoles per litre (nmol/L)., From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)|AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure, Measured in hours\* nanomoles per litre (h\*nmol/L)., From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)|Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure, Measured in nanomoles per litre (nmol/L)., From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)|Number of adverse events, Number of events., From time of dosing (visit 2, day 1) until end of study (visit 9, day 22)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-15
Completion Date: 2024-11-27
Results First Posted:
Last Update Posted: 2025-04-10
Locations: Charité Research Organisation GmbH, Berlin, 10117, Germany
URL: https://clinicaltrials.gov/show/NCT06370819