| Trial ID: | L2451 |
| Source ID: | NCT05129891
|
| Associated Drug: |
Semaglutide D
|
| Title: |
A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy Volunteers|High Blood Cholesterol Levels|Type 2 Diabetes
|
| Interventions: |
DRUG: Semaglutide D|DRUG: Semaglutide G|DRUG: Semaglutide H|DRUG: Semaglutide I|DRUG: NNC0385-0434 B|DRUG: NNC0385-0434 C|DRUG: NNC0385-0434 D|DRUG: NNC0385-0434 E
|
| Outcome Measures: |
Primary: AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose, h \* nmol/L, From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration | Secondary: Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose, nmol/L, From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration|tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API, hours, From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
384
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-11-03
|
| Completion Date: |
2023-05-04
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-29
|
| Locations: |
Altasciences Company Inc., Montreal, Quebec, H3P 3P1, Canada|Parexel International GmbH, Berlin, 14050, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT05129891
|
