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Clinical Trial Details

Trial ID: L2012
Source ID: NCT06559527
Associated Drug: Nnc0487-0111
Title: A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Obesity|Overweight
Interventions: DRUG: NNC0487-0111
Outcome Measures: Primary: AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose, Measured as hours\*nanomole per liter (h\*nmol/L)., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) | Secondary: Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose, Measured as nanomole per liter (nmol/L)., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose, Measured as hours., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose, Measured as hours., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose, Measured as liter (L), From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose, Measured as liter per hour (L/h)., From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)|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 study visit (Visit 9, Day 28)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-03-05
Results First Posted:
Last Update Posted: 2025-03-30
Locations: Charité Research Organisation GmbH, Berlin, 10117, Germany
URL: https://clinicaltrials.gov/show/NCT06559527