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Clinical Trial Details

Trial ID: L0249
Source ID: NCT05094934
Associated Drug: Nnc0385-0434 A 100 Mg
Title: A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is Tolerated in Participants With Impaired Kidney Function Compared to Participants With Normal Kidney Function
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: NNC0385-0434 A 100 mg
Outcome Measures: Primary: AUC0-24h,0434,Day10: the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 hours after last dose of oral NNC0385-0434, Measured in h\*nmol/L, From last dose (Day 10) to 24 hours post treatment (Day 11) | Secondary: Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434, nmol/L, From last dose (Day 10) to post treatment follow-up (Day 65)|tmax,0434,Day10: time from last dose administration to maximum plasma concentration of oral NNC0385-0434, h, From last dose (Day 10) to post treatment follow-up (Day 65)|t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434, h, From last dose (Day 10) to post treatment follow-up (Day 65)|CLR,0434,Day10; the renal clearance of NNC0385-0434 after last dose of oral NNC0385-0434, mL/h, From last dose (Day 10) to 48 hours post treatment (Day 12)|AUC0-24h,SNAC,Day10: the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after last dose of oral NNC0385-0434, h\*ng/mL, From last dose (Day 10) to 24 hours post treatment (Day 11)|Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434, ng/mL, From last dose (Day 10) to 24 hours post treatment (Day 11)|Cmin,SNAC,Day10; the minimum plasma concentration of SNAC before last dose of oral NNC0385-0434, nmol/L, Pre-dose (Day 10)|tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434, hours, From last dose (Day 10) to 24 hours post treatment (Day 11)|CLR,SNAC,Day10; the renal clearance of SNAC after last dose of oral NNC0385-0434, mL/h, From last dose (Day 10) to 48 hours post treatment (Day 12)|Number of treatment emergent adverse events (TEAEs), Number of events, From first dose (Day 1) until completion of the post-treatment period at follow-up (Day 65)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-09
Completion Date: 2022-08-24
Results First Posted:
Last Update Posted: 2023-12-26
Locations: Novo Nordisk Investigational Site, Berlin, 10117, Germany
URL: https://clinicaltrials.gov/show/NCT05094934