| Trial ID: | L5283 |
| Source ID: | NCT05870670
|
| Associated Drug: |
Nnc0519-0130
|
| Title: |
A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: NNC0519-0130|DRUG: Placebo
|
| Outcome Measures: |
Primary: AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period, Measured in h\*nmol/L., From pre-dose until 24 hours post-dose relative to last dose in each treatment period | Secondary: Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period, Measured in nmol/L., From pre-dose until 24 hours post-dose relative to last dose in each treatment period|Number of Treatment Emergent Adverse Events (TEAEs), Measured as number of events., From time of dosing (day 1) until completion of the follow-up visit (day 105)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-05-15
|
| Completion Date: |
2023-10-16
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-29
|
| Locations: |
SOUSEIKAI Sumida Hospital, Tokyo, 130-0004, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT05870670
|
