| Trial ID: | L5109 |
| Source ID: | NCT06642584
|
| Associated Drug: |
Semaglutide B
|
| Title: |
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IV
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy Volunteers Type 2 Diabetes
|
| Interventions: |
DRUG: Semaglutide B|DRUG: Semaglutide J|DRUG: Semaglutide L|DRUG: Semaglutide M|DRUG: Semaglutide N
|
| Outcome Measures: |
Primary: Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve, Measured in hours nanomoles per liter (h \* nmol/L)., From 0 to 24 hours after dosing on Days 122 and 132.|Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration, Measured in nanomoles per liter(nmol/L)., From 0 to 24 hours after dosing on Days 122 and 132.|Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration, Measured in hours., From 0 to 24 hours after dosing on Days 122 and 132.|t½,sema; the terminal half-life of semaglutide, Measured in hours., From 0 to 840 hours after dosing on Day 132. |
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
90
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-10-15
|
| Completion Date: |
2025-05-25
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-21
|
| Locations: |
Altasciences, Montreal, Quebec, H3P 3P1, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT06642584
|
