| Trial ID: | L5951 |
| Source ID: | NCT04878406
|
| Associated Drug: |
Nnc0480-0389
|
| Title: |
A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy Volunteers Type 2 Diabetes
|
| Interventions: |
DRUG: NNC0480-0389|DRUG: Placebo (NNC0480-0389)|DRUG: Semaglutide|DRUG: Placebo (Semaglutide)
|
| Outcome Measures: |
Primary: Number of treatment emergent adverse events (TEAEs), Count of events, From time of dosing (day 1) until completion of the follow-up visit (day 43) | Secondary: AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose, Measured in nmol\*h/L, From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)|Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose, Measured in nmol/L, From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)|AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose, Measured in nmol\*h/L, From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)|Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose, Measured in nmol/L, From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-05-18
|
| Completion Date: |
2021-07-20
|
| Results First Posted: |
|
| Last Update Posted: |
2023-05-17
|
| Locations: |
Novo Nordisk Investigational Site, Fukuoka, 812-0025, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT04878406
|
